Tapered PTG implant system Catalog & Surgical Manual
BioHorizons Tapered implants Every implant treatment presents its own challenge. BioHorizons broad portfolio of Tapered implants provides solutions for all indications. Choose from narrow-diameter 3.0mm implants to wide-diameter immediate molar implants or short 6mm-length implants to 18mm-length implants. Whatever your preference, there’s a workflow to suit your need, from fully digital to traditional workflows. guidedworkflow BioHorizons guided surgery system uses an open architecture design, providing compatibility with various software providers and guide manufacturers.* traditional workflow BioHorizons comprehensive surgical kit and wide range of prosthetics support traditional workflows. digital restorative workflow Custom abutments can be sourced through validated milling centers or designed and fabricated in-house. *Mount-free Tapered Pro, Tapered Internal, Tapered Plus, Tapered 3.0 and Tapered Tissue Level implants learnmore at biohorizons.com
2 shop online at store.biohorizons.com Table of contents Tapered PTG product information & ordering 3-4 surgical instruments 5-9 healing abutments 10 multi-unit abutments 11 instructions for use 12 surgical protocols 13 implant placement level & spacing 14 surgical kit & drill sequence 15 drill overview 16 osteotomy preparation 17 implant transfer 18 healing protocols 19 appendix 20 icon legend 21 ordering, warranty information & references 22 Tapered PTG
3 shop online at store.biohorizons.com Laser-Lok surface traditional surface • over 25 years of in vitro, animal and human studies at leading universities1 • reduced incidence of peri-implantitis compared to traditional surfaces2 • only surface shown to attract a physical, connective tissue attachment3-11 • overdenture study showing only 0.42mm of bone loss compared to 1.13mm for NobelReplace™ Select12 Laser-Lok® microchannels better science, better implants learn more at laser-lok.com Tapered PTG Tapered Internal Tapered PTG
4 shop online at store.biohorizons.com platform switch prosthetic connection body diameter implant length Laser-Lok zone design features include: • dual tapered body and aggressive threads provide stability in the pterygomaxillary region • reduced apical diameter allows for precise placement of the implant apex • unique Laser-Lok microchannels create connective tissue attachment and retain crestal bone • osteotomy matched collar preserves vital bone Tapered PTG implants BioHorizons Tapered PTG implants support full-arch treatment in severely resorbed maxillae and provide an alternative to grafting, potentially expediting treatment.* Developed in a 4.2mm diameter with 15 and 18mm lengths, the implants feature a unique, dualtapered body with aggressive buttress threads, suitable for engagement during angled placement in the posterior maxilla. This approach maximizes AP spread for full arch restorations, while maintaining high implant stability. The unique Laser-Lok microchannels create a connective tissue attachment and retain crestal bone, allowing better control of esthetic outcomes. body diameter 4.2mm prosthetic connection 3.5mm Laser-Lok zone 1.8mm apical diameter 2.2mm Tapered PTG Part Number Part Description PTG4215 Tapered PTG implant, 15mm length PTG4218 Tapered PTG implant, 18mm length *see page 12 for full indications
5 shop online at store.biohorizons.com features: • versatile, removable, hinged lid • 40% smaller and 40% lighter than other kits • easy to disassemble and assemble during cleaning • implant staging area for implant vials during surgery • use to place Tapered PTG, Tapered Pro, Tapered Internal, Plus, 3.0 and Tissue Level • empty spare slots for other instrumentation such as stop drills or extended shank drills Surgical instruments Tapered HD Surgical Kit TSK4000 Tapered HD Surgical Kit Includes the instrumentation required to place: Tapered PTG, Tapered Pro, Tapered Internal, Plus, 3.0 and Tissue Level implants. TSK3500 Tapered HD Surgical Tray (without instruments)
6 shop online at store.biohorizons.com features: • cutting flutes designed for maximum efficiency • non-reflective surface for high visibility • simplified drill markings standard implant lengths • compatible with Tapered PTG, Tapered Pro, Tapered Internal, Plus, 3.0 and Tissue Level • creates 12-20 osteotomies depending on bone density • recommended drill speed 1,500-2,000 rpm (2.0 & 2.5mm), 1,000 rpm (all others) 18.0mm length indicator 15.0mm 12.0mm 9.0mm 7.5mm 10.5mm 0mm Surgical instruments HD Drills & Bur Block Tapered HD Drills The Tapered HD drills feature highly efficient cutting flutes for crisp osteotomies in even the densest bone. Simplified drill markings correspond to the standard implant lengths. Drills should be replaced every 12-20 osteotomies for maximum cutting efficiency. Part Number Part Description TSD2020HD 2.0mm HD Drill TSD2025HD 2.5mm HD Drill TSD2028HD 2.8mm HD Drill TSD2032HD 3.2mm HD Drill TSD2037HD 3.7mm HD Drill Extended Shank HD Drills Extended Shank Drills are 8mm longer than our standard drills. Part Number Part Description TSD4020HD 2.0mm Extended Shank HD Drill TSD4025HD 2.5mm Extended Shank HD Drill TSD4028HD 2.8mm Extended Shank HD Drill TSD4032HD 3.2mm Extended Shank HD Drill TSD4037HD 3.7mm Extended Shank HD Drill
7 shop online at store.biohorizons.com 3.5/4.5mm HD Implant-level Drivers Drivers are color-coded by prosthetic connection: • 3.0mm platform - no color indicator • 3.5mm platform - yellow • 4.5mm platform - green Part Number Part Description TYGIDH Handpiece Driver TYGIDR Ratchet Driver Parallel Pins Part Number Part Description 144-100 Straight Parallel Pins (2 per kit) 144-200 20° Angled Parallel Pins (2 per kit) 144-230 30° Angled Parallel Pins (sold separately) Surgical instruments Individual Components 130-000 Ratchet 135-351 .050” (1.25mm) Hex Driver 122-100 Drill Extender 300-205 4mm Square Drive Extender 300-400 Hand Wrench TODKIT2 Tapered Offset Site Dilator Kit The Tapered Implant site dilators match the geometry of the Tapered surgical drills and are used to create or enlarge osteotomies in soft maxillary bone. These instruments compress the bone laterally rather than removing valuable bone from the surgical site, creating a more dense bone-to-implant interface.
8 shop online at store.biohorizons.com * Mount-free Tapered Pro, Tapered PTG, Tapered Internal, Tapered Plus, Tapered 3.0, Tapered Tissue Level implants. 5.2mm and 5.8mm instruments sold separately. Surgical instruments Ancillary Instruments 122-015 1.5mm Starter Drill The 1.5mm starter drill facilitates precise initiation of osteotomies and features a 10.5mm depth marking. 122-106 #6 Round Bur 122-104 Alignment Drill The alignment drill can be used to initiate the osteotomy to a depth of 5mm. The cutting surface of the drill hub prepares the crestal bone for the depth drill. 122-110 2.0mm Lindemann Bone Cutter Side-cutting drill used to correct eccentric osteotomy preparations. DB12 Bur Block Autoclavable bur block used to store up to 12 instruments. CGS4000 Guided Surgery Kit (with instruments) Includes the instrumentation required to place BioHorizons Tapered implants* Important Note about Guided Surgery Kit Surgical protocol & guide partners for the CGS4000 can be found at biohorizons.com.
9 shop online at store.biohorizons.com Surgical instruments Ancillary Instruments PYDBP 3.5mm Deep Bone Profiler Use at implant uncovery to remove excess crestal bone for proper abutment seating. Screw the guide into the implant and align the profiling bur for precise bone removal. Match profiler & guide color to prosthetic connection. 144-300 Implant Spacer / Depth Probe Use to provide intraoral measurements. Multi-functional tool for marking implant spacing on the ridge and probing osteotomy depth. BIOTORQ BioHorizons Adjustable Torque Wrench Adjustable torque wrench designed to attach to all 4mm drivers from BioHorizons. Supplied with a dual direction mechanism that allows for insertion and removal functions. When the desired torque is reached (a choice of 10Ncm to 30Ncm) the torque wrench snaps to avoid over torquing. ATW ITL Precise Adjustable Torque Wrench Place both implants and abutments with 9 distinct torque settings (15, 20, 25, 30, 35, 40, 45, 50 and 60 Ncm). A simple twist of the handle locks in precision-engineered torque values and guarantees accuracy and repeatability. AGYR-15500 Torque Control 15500 Ergonomic design is the ideal solution for access to screws placed in the posterior. The 7 predetermined torque values (10, 15, 20, 25, 30, 32 and 35 Ncm) make it a tool of extreme precision. C8521 Elos Replacement Bit, 4mm Square Adapter C8381 Elos Replacement Bit, Handpiece C12374 Elos Adjustable Torque Wrench Lightweight titanium design is easy to use as a ratchet or adjustable torque wrench with visual indicators for 15, 30, 40, 50, 60, 70, 80 and 90 Ncm. Comes packaged with a 4mm square adaptor. Quickly disassembles for cleaning. No calibration required.
10 shop online at store.biohorizons.com Use Laser-Lok healing abutments when a Laser-Lok abutment restoration is planned to inhibit epithelial downgrowth, establish a connective tissue attachment and retain crestal bone. When a LaserLok component is used and temporarily removed for impression making or other restorative procedures, keep the removed LaserLok component in sterile saline until reinserting into the site. Hand-tighten with the .050” (1.25mm) Hex Driver. Titanium Alloy. Note: See L02015-003 Handling of LaserLok Abutments for more information. abutment height Laser-Lok Hand-tighten with the .050” (1.25mm) Hex Driver. Titanium Alloy. The 3.5mm, 4.5mm and 5.7mm healing abutments are laser marked for easy intraoral identification of the prosthetic platform, emergence and height: Y = Yellow (3.5mm) platform G = Green (4.5mm) platform B = Blue (5.7mm) platform N, R or W = Narrow, Regular or Wide emergence 1, 2, 3 or 5 = 1mm, 2mm, 3mm or 5mm abutment height L = Laser-Lok 3.0 healing abutments are not laser marked due to their small size. Healing Abutments Part Description Abutment diameter 1mm height 2mm height 3mm height 5mm height Narrow 3.5mm platform 4.0mm PYNHA1 PYNHA2 PYNHA3 PYNHA5 3.5mm platform, Laser-Lok 4.0mm - - PYNHA3L PYNHA5L Regular 3.5mm platform 4.5mm - PYRHA2 PYRHA3 PYRHA5 3.5mm platform, Laser-Lok 4.5mm - - PYRHA3L PYRHA5L Wide 3.5mm platform 6.0mm - - PYWHA3 PYWHA5 3.5mm platform, Laser-Lok 6.0mm - - PYWHA3L PYWHA5L abutment height Using authentic BioHorizons parts will ensure a precision fit connection between the prosthetic component and implant, avoiding costly component failures that may occur from using third-party prosthetics. Authentic BioHorizons parts are color-coded for easy identification to match the mating implant. advantages: • lifetime warranty on all implants and prosthetics • Spiralock® technology minimizes screw loosening • precise mating geometries reduce prosthetic failures • advanced design creates a better engineered connection • color-coded prosthetic components match implant platforms authentic connection Prosthetics Healing Abutments
11 shop online at store.biohorizons.com 17° 2.25mm 3.5mm 30° 3mm 3.5mm 1mm 2.2mm 3.5mm L02015-028 Multi-unit abutment hybrid or fixed-detachable-screw-retained restoration module L02015-029 Multi-unit abutment bar overdenture - screw-retained restoration module L02015-031 Correcting a non-passive framework module L02015-003 Handling of Laser-Lok abutments module 5mm 4mm 3mm 2mm 1mm Straight Laser marking 17°Angled Laser marking 30°Angled Laser marking 5mm 4mm 3mm 4mm 3mm 2.25mm Prosthetics Multi-unit Abutments Straight Multi-unit Abutments Straight Multi-unit abutments may be used for multiple-unit restorations including: screwretained restorations at the abutment level, cast alloy bars for overdentures and fixed/ detachable (hybrid) restorations. Comes with a cover cap (PXMUCC). Final torque: 30 Ncm using a Multi-unit Hex Adapter. Titanium alloy. Part Description 1mm collar 2mm collar 3mm collar 4mm collar 5mm collar 3.5mm platform PYMU1 PYMU2 PYMU3 PYMU4 PYMU5 3.5mm platform, Laser-Lok - PYMU2L PYMU3L PYMU4L - Angled Multi-unit Abutments Angled Multi-unit abutments may be used to angle-correct divergent implants. Use for multiple-unit restorations including: screw-retained restorations at the abutment level, cast alloy bars for overdentures and fixed/detachable (hybrid) restorations. Comes with a cover cap (PXMUCC) and abutment screw (PXMUAS). Final torque: 30 Ncm. Titanium alloy. Conveniently deliver abutment one-handed using an .050 hex or Unigrip™ driver or two-handed using an angled Multi-unit carrier (MUCA). Part Description 2.25mm collar 3mm collar 4mm collar 5mm collar 17° angle, 3.5mm platform PYMU172 PYMU173 PYMU174 PYMU174 30° angle, 3.5mm platform - PYMU303 PYMU304 PYMU305 Multi-unit Try-in Abutments Each Try-in is laser marked to correspond with the Multi-unit Abutment collar heights, and can also be used as a measuring tool for OD Secure, Locator, Locator R-Tx and Ball abutment systems. Try-in is carried to the site by the handle and snaps into the implant. Multi-unit Try-in Abutments may be used to measure tissue thickness and verify proper prosthetic seating prior to final abutment seating. Part Number Part Description TRYPYMU 3.5mm Multi-unit Try-in Straight Abutment TRYPYMU17 3.5mm Multi-unit Try-in 17° Angled Abutment TRYPYMU30 3.5mm Multi-unit Try-in 30° Angled Abutment
12 shop online at store.biohorizons.com This surgical manual serves as a reference for using the Tapered PTG implants and surgical instruments. It is intended solely to provide instructions on the use of BioHorizons products. It is not intended to describe the methods or procedures for diagnosis, treatment planning, or placement of implants, nor does it replace clinical training or a clinician’s best judgment regarding the needs of each patient. BioHorizons strongly recommends appropriate training as a prerequisite for the placement of implants and associated treatment. The procedures illustrated and described within this manual reflect idealized patient presentations with adequate bone and soft tissue to accommodate implant placement. No attempt has been made to cover the wide range of actual patient conditions that may adversely affect surgical and prosthetic outcomes. Clinician judgment as related to any specific case must always supersede any recommendations made in this or any BioHorizons literature. Before beginning any implant surgical procedure with BioHorizons implants: • Read and understand the Instructions for Use that accompany the products. • Clean and sterilize the surgical tray and instruments per Instructions for Use. • Become thoroughly familiar with all instruments and their uses. • Study surgical kit layout and iconography. • Design a surgical treatment plan to satisfy the prosthetic requirements of the case. Small diameter implants are intended for the anterior region of the mouth and are not intended for the posterior region of the mouth due to possible failure of the implant. Indications Tapered PTG, Tapered Pro, Tapered Internal, Tapered Plus and Tapered Tissue Level Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately: 1) with a temporary prosthesis that is not in functional occlusion or 2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants. Because of their length and diameter, BioHorizons Tapered PTG implants are well-suited for implant placement through the maxillary tuberosity in the pterygoid plate, supporting full-arch treatment in extremely atrophic maxillae and providing an alternative to grafting, which may expedite treatment.13,14 Tapered Internal 3.0 and Tapered Tissue Level 3.0 Implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately: (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading. Important Considerations • Peri-operative oral rinses with a 0.12% Chlorhexidine Digluconate solution have been shown to significantly lower the incidence of post-implantation infectious complications.15 A pre-operative 30-second rinse is recommended, followed by twice daily rinses for two weeks following surgery. • Drilling must be done under a constant stream of sterile irrigation. A pumping motion should be employed to prevent over-heating the bone. Surgical drills and taps should be replaced when they are worn, dull, corroded or in any way compromised. BioHorizons recommends replacing drills after 12 to 20 osteotomies.16 A Drill-usage Tracking Chart is available at biohorizons.com to record this important information. • There is a risk of injury to the mandibular nerve associated with surgical drilling in posterior mandibular regions. To minimize the risk of nerve injury, it is imperative that the clinician understands the drill depth markings as they relate to the implant length to produce the desired vertical placement of the implant. Surgical Manual Instructions for Use
13 shop online at store.biohorizons.com Two-Stage Protocol In a two-stage surgery, the implant is placed below the soft tissue and protected from occlusal function and other forces during osseointegration. A low-profile cover cap is placed on the implant to protect it from the ingress of soft tissue. Following osseointegration, a second procedure exposes the implant and a transmucosal healing abutment is placed to allow for soft tissue healing and development of a sulcus. Prosthetic restoration begins after soft tissue healing. Single-stage Protocol Single-stage surgery may be accomplished by placing a healing abutment at the time of implant surgery. This eliminates the need for a second procedure. Although the implant is not in occlusal function, some forces can be transmitted to it through the exposed transmucosal element. Prosthetic restoration begins following osseointegration of the implant and soft tissue healing. Non-functional Immediate Restoration Single-stage surgery with non-functional immediate provisionalization provides the patient a non-functioning provisional prosthesis early in the treatment plan. An abutment is placed on the implant at or shortly after surgery, and a provisional restoration is secured using temporary cement. The provisional can help contour the soft tissue profile during healing. Immediate Function Restoration Single-stage surgery with immediate function is possible in good quality bone where multiple implants exhibiting excellent initial stability can be splinted together. Splinting implants together may offer a biomechanical advantage over individual, unsplinted prostheses. Implant with cover cap in a two-stage protocol. Implants with a splinted prosthesis in immediate function. Implant with healing abutment in a single-stage protocol. Implant restored with a nonfunctional provisional prosthesis. Surgical Manual Surgical Protocols
14 shop online at store.biohorizons.com Implant-to-Implant Spacing The osteotomy center-to-center measurement required to maintain a specific edge-to-edge spacing between two implants is calculated according to this formula: 1/2 (sum of 2 implant body diameters) + the desired spacing. Implant-to-Tooth Spacing The osteotomy centerpoint required to maintain a specific implant-to-tooth spacing is calculated according to this formula: 1/2 (implant body diameter) + the desired spacing. During implant placement, clinicians must apply their best judgment as to the appropriate spacing for individual patient conditions. During implant placement, clinicians must apply their best judgment as to the appropriate spacing for individual patient conditions. osteotomy centerpoint edgeto-edge spacing Placement in Uneven Ridges When placing the implant in an uneven ridge, prepare the osteotomy and place the implant so the bone/soft-tissue junction is within the Laser-Lok transition zone. This will allow both soft tissue and bone to attach to the Laser-Lok collar. If the ridge discrepancy is more than the Laser-Lok transition zone, leveling the ridge can be considered. implantto-tooth spacing osteotomy centerpoint Surgical Manual Implant Placement Level & Spacing
15 shop online at store.biohorizons.com Surgical Kit Instructions The surgical kit uses an intuitive layout to guide the surgeon through the instrument sequence. The sequence begins in the upper left hand corner and works left-to-right. Tapered HD drills increase in diameter as you work through the sequence from left-to-right. Abutment-level drivers are only for mounted implants. The implant driver section is colorcoded by prosthetic platform (gray=3.0mm, yellow=3.5mm, green=4.5mm and blue=5.7mm). Prior to use, clean and sterilize the surgical tray and instruments according to the Instructions for Use included with the kit. Study the surgical kit layout, color coding and iconography. Surgical assistants should be thoroughly familiar with all instruments and their uses prior to initiating the surgical procedure. PTG4215 drill sequence TSD4020HD TSD2032HD TSD2037HD 15mm depth 12mm depth 12mm depth Starter Intermediate Final Recommended Speed (RPM) 1,500-2,000 1,000 PTG4218 drill sequence TSD4020HD TSD2032HD TSD2037HD 18mm depth 15mm depth 15mm depth Starter Intermediate Final Recommended Speed (RPM) 1,500-2,000 1,000 Drill Sequence The intermediate drill may be used as a final drill in soft bone. The final drill is recommended for use in dense bone. Surgical Manual Surgical Kit & Drill Sequence Tapered HD drills Tapered Implant Drivers
16 shop online at store.biohorizons.com Drill Markings All surgical drills included with this system are externally irrigated and designed to be used with steady sterile irrigation. Reduced drill speed may be indicated in softer bone or as drill diameter increases. Note: The depth marks are consistent throughout the starter drills, depth drills and width increasing drills. 18.0mm length indicator 15.0mm 12.0mm 9.0mm 7.5mm 10.5mm 0mm 2.0mm Starter Drill Purpose: Initiate osteotomy. • Chisel-tip design eliminates “skating” on osseous crest • Prepares site for paralleling pins • Matte finish for increased visibility under operatory lights •1,500 - 2,000 RPM 2.0mm HD Drill The 2.0mm depth drills are designed to increase and/or set the depth of the osteotomy. An extended shank 2.0 drill is recommended to reach the appropriate depth for 18mm length implants. Surgical Manual Drill Overview
17 shop online at store.biohorizons.com Paralleling Pins Purpose: Evaluate osteotomy position and angle. • Provided straight or with a 20° angle • Use after 2.0mm Starter Drill • 9mm shank for radiographic evaluation of proximity to adjacent anatomy • Hub diameter is 4.0mm HD Drills Purpose: Incrementally widen the osteotomy to reduce heat generation. • Depth-marked for reference • Efficient cutting drill design collects bone for autografting • The drill tip has limited end cutting. However, the osteotomy depth can be increased with these drills as needed • Matte finish for increased visibility under operatory lights •1,000 RPM Implant & Abutment Drivers Purpose: Engage the implant’s internal hex to drive implants into the osteotomy. • Implant level drivers are color-coded by prosthetic connection: yellow/green=3.5/4.5mm platform • 30 rpm or less17 Surgical Manual Osteotomy Preparation
18 shop online at store.biohorizons.com * except 18mm length Internal Hex Orientation When seating the implant, use the corresponding dimples on the driver to orient one internal hex flat perpendicular to the implant angulation plane. Doing so verifies that an angled abutment will correct the angulation. Implant Placement Place the apex of the implant into the osteotomy and begin rotating slowly. PEEK snap ring driver hex Implant Pick-up To pick-up the implant, align the driver hex with the implant hex and press firmly to engage the PEEK snap ring. dimple If too much resistance is felt during insertion, reverse the implant to relieve pressure and re-insert into the osteotomy. If the final drill was not used while preparing the osteotomy, remove the implant and revise the osteotomy with the final drill. Surgical Manual Implant Transfer hex flat
19 shop online at store.biohorizons.com Immediate Provisional Restorative Options Temporary Abutments Purpose: Titanium and PEEK temporaries are easily modified for fabrication of cement or screw-retained provisional restorations. A long direct coping screw (purchased separately) may be used to maintain the screw access hole during the fabrication of a screw-retained provisional prosthesis. cover cap Cover Caps for Two-stage Protocol Purpose: Protects prosthetic platform in two-stage (submerged) surgical protocol for bone level implants. • Irrigate implant to remove blood and other debris: • Use an antibacterial paste to decrease the risk of bacterial growth • Thread clockwise into implant body • Color-coded by prosthetic platform • Hand-tighten (10-15 Ncm) utilizing .050” (1.25mm) Hex Driver The cover cap for the mount-free implant is mounted in the vial cap. Healing Abutments for Single-stage Protocol Purpose: Transmucosal element for developing soft tissue emergence with narrow, regular, wide emergence or Simple Solutions prosthetic components. • Color-coded by prosthetic platform • The 3.5, 4.5mm and 5.7mm healing abutments are laser marked for easy intraoral identification; for example: YR3=Yellow (3.5mm) platform / Regular Emergence / 3mm High • If a Laser-Lok temporary or final restoration is planned, a Laser-Lok healing abutment is required • Hand-tighten (10-15 Ncm) utilizing .050” (1.25mm) Hex Driver Surgical Manual Healing Protocols
20 shop online at store.biohorizons.com Post-operative Instructions A period of unloaded healing time is often recommended to allow for integration between the bone and implant surface. This is dependent on individual patient healing rates and bone quality of the implant site. Each case must be independently evaluated. The patient should be instructed to follow a post-surgical regimen including cold packs for 24 hours post-implantation. The patient’s diet should consist of soft foods and possibly dietary supplements. Pharmacological therapy should be considered as the patient’s condition dictates. If a removable prosthesis is used during the initial healing phase, a soft liner material should be used to prevent pressure on the surgical site. Relieve the prosthesis over the implant site prior to the soft liner application. Periodically check the patient’s soft tissue and bone healing using clinical and radiographic evaluations. Ongoing hygiene for the implant patient is vital. Hygiene recall appointments at three month intervals are suggested. Instruments designed for implant abutment scaling, such as Implacare® instruments from Hu-Friedy® should be utilized. The stainless steel handles may be fitted with assorted tip designs for hygiene on natural teeth. The Implacare® scalers contain no glass or graphite fillers that can scratch titanium implant abutments. Do not use the profiler without the guide in place. Using an .050” hex driver, remove the surgical cover cap from the implant and place the profiler guide that matches the color of the prosthetic platform. Use the profiler with copious amounts of sterile irrigation. Once the excess bone and soft tissue are removed, unscrew the guide and seat the appropriate prosthetic component. Image showing exceptional bone growth at 3 months. (Myron Nevins, DDS.) Bone Profilers Purpose: In cases where excess crestal bone has been created, use a bone profiler at implant uncovery to contour the bone. This will provide the necessary clearance for proper abutment seating. • Profiler guide protects implant platform • Color-coded by prosthetic platform (gray=3.0mm, yellow=3.5mm, green=4.5mm, blue=5.7mm) • 800 rpm drill speed with steady sterile irrigation Surgical Manual Appendix
21 shop online at store.biohorizons.com Tapered PTG Implant Laser-Lok, RBT 4.2 x 15mm, 3.5 Plat (01) 00847236010119 (17) YYMMDD (11) YYMMDD (10) YYXXXXX LPTG4215B REV B -DD -DD ES IMPLANTE body diameter prosthetic platform 4.2mm 3.5mm (yellow internal hex & cover cap) Tapered PTG Product Labeling Lot/batch number LOT Reference/ article number REF Manufacture date (YYYY-MM-DD) Use before expiration date (YYYY-MM-DD) Sterile by gamma irradiation Non-sterile NON-STERILE R STERILE BioHorizons products carry the CE mark and fulfill the requirements of the Medical Devices Directive 93/42/EEC 2797 EU Authorised Representative Quality First International OÜ Laki 30 12915 Tallinn Estonia Tel +372-610-4196 Label number Symbol Descriptions for Product Labeling Surgical Manual Icon Legend Caution: Federal (USA) law restricts these devices to the sale, distribution and use by, or on the order of, a dentist or physician. Rx Only Single use only
22 shop online at store.biohorizons.com ORDERING, WARRANTY INFORMATION AND REFERENCES BioHorizons Lifetime Warranty on Implants and Prosthetics: All BioHorizons implants and prosthetic components include a Lifetime Warranty. BioHorizons implant or prosthetic components will be replaced if removal of that product is due to failure (excluding normal wear to overdenture attachments). Additional Warranties: BioHorizons warranties surgical drills, taps and other surgical and restorative instruments. (1) Surgical Drills and Taps: Surgical drills and taps include a warranty period of ninety (90) days from the date of initial invoice. Surgical instruments should be replaced when they become worn, dull, corroded or in any way compromised. Surgical drills should be replaced after 12 to 20 osteotomies.16 (2) Instruments: The BioHorizons manufactured instrument warranty extends for a period of one (1) year from the date of initial invoice. Instruments include drivers, implant site dilators and BioHorizons tools used in the placement or restoration of BioHorizons implants. Return Policy: Product returns require a Return Authorization Form, which may be acquired by contacting Customer Care. The completed Return Authorization Form must be included with the returned product. For more information, please see the reverse side of the invoice that was shipped with the product. Disclaimer of Liability: BioHorizons products may only be used in conjunction with the associated original components and instruments according to the Instructions for Use (IFU). Use of any non-BioHorizons products in conjunction with BioHorizons products will void any warranty or any other obligation, expressed or implied. Treatment planning and clinical application of BioHorizons products are the responsibility of each individual clinician. BioHorizons strongly recommends completion of postgraduate dental implant education and adherence to the IFU that accompany each product. BioHorizons is not responsible for incidental or consequential damages or liability relating to use of our products alone or in combination with other products other than replacement or repair under our warranties. Distributed Products: For information on the manufacturer’s warranty of distributed products, please refer to their product packaging. Distributed products are subject to price change without notice. Validity: Upon its release, this literature supersedes all previously published versions. Availability: Not all products shown or described in this literature are available in all countries. BioHorizons continually strives to improve its products and therefore reserves the right to improve, modify, change specifications or discontinue products at any time. Any images depicted in this literature are not to scale, nor are all products depicted. Product descriptions have been modified for presentation purposes. For complete product descriptions and additional information, visit store.biohorizons.com. 1. Incidence of Peri-Implant Diseases on Implants with and without Laser-Microgrooved Collar: A 5-Year Retrospective Study Carried Out in Private Practice Patients. Guarnieri R, Grande M, Zuffetti F, Testori T. Int J Oral Maxillofac Implants. 2018 Mar/Apr;33(2):457-465. 2. For a complete research summary, please see Laser-Lok Clinical Overview (BioHorizons document ML0606). 3. Human histologic evidence of a connective tissue attachment to a dental implant. M Nevins, ML Nevins, M Camelo, JL Boyesen, DM Kim. International Journal of Periodontics & Restorative Dentistry. Vol. 28, No. 2, 2008. 4. The effects of laser microtextured collars upon crestal bone levels of dental implants. S Weiner, J Simon, DS Ehrenberg, B Zweig, JL Ricci. Implant Dentistry. Volume 17, Number 2, 2008. p. 217-228. 5. Influence of a microgrooved collar design on soft and hard tissue healing of immediate implantation in fresh extraction sites in dogs. SY Shin, DH Han. Clin. Oral Impl. Res. 21, 2010; 804–814. 6. Maintaining inter-implant crestal bone height via a combined platform-switched, Laser-Lok® implant/abutment system: A proof-of-principle canine study. M Nevins, ML Nevins, L Gobbato,HJ Lee, CW Wang, DM Kim. Int J Periodontics Restorative Dent. Volume 33, Number 3, 2013. 7. Histologic evidence of a connective tissue attachment to laser microgrooved abutments: A canine study. M Nevins, DM Kim, SH Jun, K Guze, P Schupbach, ML Nevins. International Journal of Periodontics & Restorative Dentistry. Vol. 30, No. 3, 2010. 8. Histologic evidence of connective tissue integration on laser microgrooved abutments in humans. NC Geurs, PJ Vassilopoulos, MS Reddy. Clinical Advances in Periodontics. Vol. 1, No. 1, May 2011. 9. Connective tissue attachment to laser microgrooved abutments: A human histologic case report. M Nevins, M Camelo, ML Nevins, P Schupbach, DM Kim. Int J Periodontics Restorative Dent. Volume 32, Number 4, 2012. p. 384-392. 10. Reattachment of the connective tissue fibers to the laser microgrooved abutment surface. M Nevins, M Camelo, ML Nevins, P Schupbach, DM Kim. Int J Periodontics Restorative Dent. Volume 32, Number 4, 2012. e131-134. 11. The impact of dis-/reconnection of laser microgrooved and machined implant abutments on soft- and hard-tissue healing. Iglhaut G, Becker K, Golubovic V, Schliephake H, Mihatovic I. Clin Oral Implants Res. 2013 Apr;24(4):391-7. 12. The effects of laser microtexturing of the dental implant collar on crestal bone levels and peri-implant health. S Botos, H Yousef, B Zweig, R Flinton and S Weiner. Int J Oral Maxillofac Implants. 2011;26:492-498. 13. Glossary of Oral and Maxillofacial Implants. WR Laney. Int J Oral Maxillofac Imp. Jul/Aug 2017;32(4):Gi-G200. 14. Pterygoid implant: option for the rehabilitation of the atrophic posterior maxilla. PVR Nag, P Sarika, T Bhagwatkar, V Dhara. Int J Contemp Dent Med Rev. 2019;1-5 15. The influence of 0.12 percent chlorhexidine digluconate rinses on the incidence of infectious com-plications and implant success. Lambert PM, Morris HF, Ochi S. J Oral Maxillofac Surg. 1997;55(12 supplement 5):25-30. 16. Heat production by 3 implant drill systems after repeated drilling and sterilization. Chacon GE, Bower DL, Larsen PE, McGlumphy EA, Beck FM. J Oral Maxillofac Surg. 2006 Feb;64(2):265-9. 17. Root Form Surgery in the Edentulous Mandible: Stage I Implant Insertion. CE Misch. Contemporary Implant Dentistry Second Edition. Mosby: St. Louis, 1999. 347-369. References
*L01077* *REV A JUL 2020* L01077 REV A JUL 2020 shop online at store.biohorizons.com Direct Offices Distributors For contact information in our 90 countries, visit biohorizons.com BioHorizons USA 888-246-8338 or 205-967-7880 BioHorizons Canada 866-468-8338 BioHorizons Chile +56 (2) 23619519 BioHorizons Spain +34 91 713 10 84 BioHorizons Italy 800-063-040 BioHorizons UK +44 (0)1344 752560 BioHorizons Mexico 800-953-0498 BioHorizons®, Laser-Lok®, MinerOss®, AutoTac®, Mem-Lok® and TeethXpress® are registered trademarks of BioHorizons. Unigrip™ is a trademark of Nobel Biocare AB. Zimmer® Dental ScrewVent® and Tapered ScrewVent® are registered trademarks of Zimmer, Inc. AlloDermTM, AlloDerm GBRTM and NovoMatrixTM are trademarks of LifeCell Corporation, an Allergan affiliate. Grafton® DBM is a registered trademark of Medtronic, Inc. Cytoplast® is a registered trademark of Osteogenics Biomedical, Inc. Puros Dermis is a registered trademark of Zimmer Biomet. Mucograft is a registered trademark of Ed. Geistlich Sogne Ag Fur Chemische Industrie. Symbios PerioDerm is a registered trademark of Dentsply Sirona. Hu-Friedy® is a registered trademark of Hu-Friedy Mfg. Co., LLC. Spiralock® is a registered trademark of Spiralock Corporation. Pomalux® is a registered trademark of Westlake Plastics Co. Locator® is a registered trademark of Zest Anchors, Inc. Delrin® is a registered trademark of E.I. du Pont de Nemours and Company. Bio-Gide® is a registered trademark of Edward Geistlich Sohne AG Fur Chemische Industrie. BioMend® is a registered trademark of Zimmer Biomet Dental. IntraSpin®, L-PRF® and Xpression® are trademarks of Intra-Lock® International Inc. Not all products shown or described in this literature are available in all countries. As applicable, BioHorizons products are cleared for sale in the European Union under the EU Medical Device Directive 93/42/EEC and the tissues and cells Directive 2004/23/EC. We are proud to be registered to ISO 13485:2016, the international quality management system standard for medical devices, which supports and maintains our product licences with Health Canada and in other markets around the globe. Original language is English. ©BioHorizons. All Rights Reserved.
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