← Product Code [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE) · K960026 # BIOHORIZONS DENTAL IMPLANT SYSTEM (K960026) _BioHorizons Implant Systems, Inc. · DZE · Mar 28, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K960026 ## Device Facts - **Applicant:** BioHorizons Implant Systems, Inc. - **Product Code:** [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE.md) - **Decision Date:** Mar 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3640 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The BioHorizons Dental Implant System may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention. ## Device Story System comprises screw-form dental implants, surgical components, and prosthetic components; designed for mandible and maxilla. Implants feature varied thread depth, thread form, and pitch to optimize strain distribution across four bone density classifications (D1-D4). Used by dental clinicians to provide artificial root structures for tooth replacement or denture retention. Benefits include improved biomechanical performance and interface maintenance under functional loading. Implants are available in 4mm and 5mm diameters with glass bead, titanium plasma-spray (TPS), or hydroxyapatite (HA) coatings. ## Clinical Evidence Bench testing only. Evidence includes closed-form calculations, finite element analyses, implant mechanical tests, and bioactive coating mechanical tests. ## Technological Characteristics Materials: Titanium alloy (ASTM F 136). Coatings: Glass bead, titanium plasma spray (TPS), hydroxyapatite (HA). Design: Screw-form with variable thread depth, form, and pitch based on bone density (D1-D4). Diameters: 4mm, 5mm. Lengths: 9-15mm. ## Regulatory Identification An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function. ## Special Controls *Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use. ## Predicate Devices - Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants - Branemark System® Implants ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} BioHorizons Implant Systems, Inc. 510(k) Notification December 30, 1995 K960024 K960026 # 510(k) Summary of Safety and Effectiveness ## Proprietary Name BioHorizons Dental Implant System (name subject to change) ## Common Name Uncoated, titanium plasma spray, and hydroxyapatite screw-form implants, surgical components, and prosthetic components ## Classification Name Endosseous implants, surgical components, and prosthetic attachments ## Classification Class III ## Official Contact R. Steven Boggan, M.S., M.BA. Vice President Of Research and Development BioHorizons Implant Systems, Inc. 2129 Montgomery Highway Birmingham, AL 35209 (205) 871-1345 FAX (205) 870-0304 ## Device Description The BioHorizons Dental Implant System is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This improvement in biomechanical performance is achieved by optimizing implant designs specifically for each bone density classification (D1, D2, D3, D4) in the mandible and maxilla. Four implant designs, corresponding to each bone density classification, are available in four and five mm diameters. Each implant design, manufactured from titanium alloy 0000014 {1} BioHorizons Implant Systems, Inc. 510(k) Notification December 30, 1995 conforming to ASTM F 136, is available in two lengths and may feature a glass bead, titanium plasma-spray (TPS), or hydroxyapatite (HA) coating. The following table provides a comprehensive summary of implant diameter, length, and coating. | Diameter (mm) | Design | Lengths (mm) | Coating | | --- | --- | --- | --- | | φ4.00 | D1 | 10, 12 | Glass Bead | | | D2 | 11, 13 | TPS | | | D3 | 12, 14 | HA | | | D4 | 13, 15 | HA | | φ5.00 | D1 | 9, 11 | Glass Bead | | | D2 | 10, 12 | TPS | | | D3 | 11, 13 | HA | | | D4 | 12, 14 | HA | The body of each implant includes a significant enhancement of the basic screw-form implant macrodesign to optimize the implants for specific regions of the mandible and/or maxillary bone. This objective is accomplished by varying the thread depth and thread form within and between each implant design. Pitch is varied between the four implant designs. ## Product Evaluation Evaluation of the BioHorizons Dental Implant System consisted of (1) closed form calculations, (2) finite element analyses, (3) implant mechanical tests, and (4) bioactive coating mechanical tests. These analyses indicate that the BioHorizons Dental Implant System should be safe and effective when used as intended. ## Indications The BioHorizons Dental Implant System may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention. ## Substantial Equivalence Information The BioHorizons Dental Implant System is substantially equivalent in all features which could affect safety or effectiveness to the Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants and the Branemark System® Implants 0000015 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K960026](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K960026) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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