BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)
Device Facts
| Record ID | K964330 |
|---|---|
| Device Name | BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) |
| Applicant | BioHorizons Implant Systems, Inc. |
| Product Code | DZE · Dental |
| Decision Date | Jan 17, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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 endosseous screw-form implants, surgical components, and prosthetic components. Implants designed for specific bone density classifications (D1-D4) in mandible and maxilla to optimize strain distribution and promote bone growth. Available in 4mm and 5mm diameters; various lengths. Materials include titanium alloy with optional titanium plasma-spray (TPS) or hydroxyapatite (HA) coatings. Used by dental clinicians for tooth replacement or prosthetic support. Device provides artificial root structure; clinical benefit includes functional loading support and interface maintenance.
Clinical Evidence
Bench testing only. Evaluation consisted of mechanical testing of the implant and bioactive coating mechanical tests.
Technological Characteristics
Titanium alloy (ASTM F 136). Screw-form endosseous implants. Coatings: Uncoated, titanium plasma spray (TPS), or hydroxyapatite (HA). Diameters: 4mm, 5mm. Lengths: 9mm-15mm. Design optimized for bone density classifications D1-D4.
Indications for Use
Indicated for patients requiring single tooth replacement or abutments for fixed bridgework and denture retention in the mandible and maxilla.
Regulatory Classification
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
- BioHorizons Dental Implant System (K960026)
- Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants
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