18 shop online at store.biohorizons.com LABELING, ORDERING & WARRANTY INFORMATION BioHorizons Lifetime Warranty on Implants and Prosthetics for clinicians: 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.1 (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. (01) 00847236009328 (11) YYMMDD (10) YYXXXXX LTSGKIT Rev B -DD manufactured by: BioHorizons 2300 Riverchase Center Birmingham, AL 35244 USA TEL +205-967-7880 EU Authorised Representative QUALITY FIRST INTERNATIONAL OÜ Laki 30 12915 Tallinn Estonia Tel +372-610-4196 TSGKIT YYXXXXX LOT REF Non-Sterile Tapered Guided Surgery Kit see instructions for use http://ifu.biohorizons.com 2797 Lot/batch number Reference/article number LOT REF Rx Only Artwork label number Symbol Descriptions for Product Labeling EU Authorised Representative Quality First International OÜ Laki 30 12915 Tallinn Estonia Tel +372-610-4196 see instructions for use http://ifu.biohorizons.com Caution: Federal (USA) law restricts these devices to the sale, distribution and use by, or on the order of, a dentist or physician. Non-sterile Non-Sterile 1. Implant success rate is the weighted average of all published human studies on BioHorizons implants. These studies are available for review in BioHorizons document numbers ML0606 and ML0130. 2. The influence of 0.12 percent chlorhexidine digluconate rinses on the incidence of infectious complications and implant success. Lambert PM, Morris HF, Ochi S. J Oral Maxillofac Surg 1997;55(12 supplement 5):25-30. 3. 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. BioHorizons products carry the CE mark and fulfill the requirements of the Medical Devices Directive 93/42/EEC 2797
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