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This document supersedes all prior revisions. Original language is English.
This document applies to BioHorizons Dental Instruments and Accessories. Every product packaging label contains a
description of the enclosed device.
DESCRIPTION
BioHorizons instruments are used for dental implant procedures such as site development, implant placement, and implant
restorations within the specific indications of each implant system. The label on each instrument contains important product
information including whether the instrument is supplied sterile or non-sterile and if the instrument is for single-use only.
Instruments and kits supplied non-sterile must be cleaned and sterilized prior to first use and each use thereafter.
INDICATIONS FOR USE
BioHorizons instruments and surgical kits are indicated for use in site development, placement, and restoration of BioHorizons
implants and associated components. The BioHorizons Single Use Drills are indicated for use with the BioHorizons Tapered
Internal and Laser-Lok 3.0 implants only. No attempt should be made to re-use or re-sterilize the drills. BioHorizons assumes
no responsibility for attempted re-use or re-sterilization between patients.
CONTRAINDICATIONS
BioHorizons instruments should not be used with patients that have allergies to the specific materials used, including stainless
steel and titanium alloy.
DIRECTIONS FOR USE
Proper surgical procedures and restorative techniques are the responsibility of the medical professional. Each clinician must
evaluate the appropriateness of the procedure used based on personal medical training and experience as applied to the patient
case at hand. BioHorizons strongly recommends completion of dental implant courses and strict adherence to the instructions
pertaining to BioHorizons products.
Internal Abutment-level Driver, Hex-chuck Handpiece: Use only with compatible W&H Hexagon Chucking System handpieces.
Drills and Taps: Should be replaced when wear is noticed, such as a decrease in cutting efficiency or when signs of discoloration
appear. Cutting instruments should be replaced after approximately 12 to 20 osteotomy cycles, depending on bone density.
BioHorizons recommends use of a drill usage chart to track drill use and to ensure drills are replaced as directed. Single Use
Drills: Insert the drill into a handpiece and twist protective tubing off prior to use. CGS Drills and Guides: Care must be taken to
ensure the CGS Drills follow the angle of the guide handle inserts or sleeves to prevent drill binding. Refer to the drill report for
proper drill selection and usage. Site Dilators: Push the dilator into the bone while rotating it. In firmer bone, it may be necessary
to use a mallet to tap the dilator to proper depth. Laser-Lok Protective Sleeves: Secure Titanium Base Abutments onto the
sleeve side labeled Hybrid or Custom Titanium Abutments onto the side labeled Full Ti to protect Laser-Lok region during
bonding and polishing.
The BioHorizons Simple Solutions Replica Lab Tools are hand instruments to aid in the fabrication of burnout wax copings for
Simple Solution restorative protocols only. They may be used in the dental suite or lab and mimic the geometry and size of the
corresponding Simple Solution Abutment and/or Replica without retentive snap feature, allowing the wax coping(s) to be
removed without deformation after hardening. The replica lab tools are manufactured of titanium alloy.
WARNINGS AND PRECAUTIONS
Clinician judgment, as related to individual patient presentations, must always supersede recommendations in any BioHorizons
Instructions for Use (IFU). Refer to OSHA standard 29CFR1910.1030 prior to cleaning and sterilization. Additional technical
information is available upon request from BioHorizons, or may be viewed and/or downloaded at www.biohorizons.com. Contact
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