BioHorizons Tapered Short Implants
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172576 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
BioHorizons Tapered Short Implants are dental implants available in 6mm and 7.5mm lengths, designed for optimal primary stability and minimal bone grafting needs. These implants feature a tapered design and incorporate the Laser-Lok® surface technology.
The implants are part of the BioHorizons Tapered implant system, which includes various diameter options from 3.0mm to wider immediate molar implants and lengths from 6mm to 18mm. They are supplied as part of a surgical system and are intended for dental applications. The device has received FDA 510(k) clearance with product code DZE.
Frequently asked questions
What are the BioHorizons Tapered Short Implants designed for?
These dental implants are designed for optimal primary stability and minimal bone grafting needs, available in 6mm and 7.5mm lengths with a tapered design incorporating Laser-Lok® surface technology.
What sizes and options are available for the BioHorizons Tapered Short Implants?
The implants are available in 6mm and 7.5mm lengths and are part of the BioHorizons Tapered implant system which includes various diameter options from 3.0mm to wider immediate molar implants.
What regulatory clearance do the BioHorizons Tapered Short Implants have?
The device has received FDA 510(k) clearance with product code DZE, determined to be substantially equivalent to predicate devices for dental applications.
How are the BioHorizons Tapered Short Implants supplied?
The implants are supplied as part of a surgical system that includes various components needed for dental implant procedures, though specific packaging details aren't provided in the available information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tapered Short Dental Implants | 6mm and 7.5mm - BioHorizons, Tapered Dental Implants - BioHorizons, Tapered Short surgical system - BioHorizons, BioHorizons US Online Store. Tapered Short
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172576 | Class II | Active |
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Manufacturer
- Manufacturer
- BioHorizons Implant Systems, Inc.
Sources (1)
- FDA 510(k) K172576 24 fields · synced Sep 25, 2026