BioHorizons Laser-Lok 3.0 Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093321 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)
The BioHorizons Laser-Lok 3.0 Implant System is a dental implant designed to promote connective tissue attachment. It features a Laser-Lok treated collar on an anatomically tapered body to support bone and soft tissue stability.
This system is indicated for use in dental procedures and is compatible with various components including impression copings, abutments, and scan bodies. The device has received FDA 510k clearance under the traditional pathway.
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: LaserLok: Next-Gen Dental Implant Solutions - BioHorizons, BioHorizons Laser-Lok 3.0 Dental Implant | SpotImplant - None, Tapered 3mm Dental Implants | Narrow Body - BioHorizons
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093321 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioHorizons Implant Systems, Inc.
Sources (1)
- FDA 510(k) K093321 24 fields · synced Sep 27, 2026