Bio-Oss Pure Nat Hydroxyapatite Endoss Implant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K871773 FDA 510(k)
- FDA Product Code
- LYC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3930 FDA 510(k)
- Regulation Number
- 872.3930 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SN FDA 510(k)
The Bio-Oss Pure Nat Hydroxyapatite Endoss Implant is a bone grafting material made from synthetic hydroxyapatite. It is designed to support bone regeneration and implant survival through its osteoconductive properties.
This device is supplied for dental use and is regulated as a Class II medical device with FDA 510(k) clearance. It is available in various sizes and is intended for use in bone regeneration procedures in dental applications.
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: Bio-oss Pure Nat Hydroxyapatite Endoss Implant, Geistlich Bio-Oss - Geistlich Pharma AG, PDF Geistlich Bio-Oss®
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K871773 | Class II | Active |
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Manufacturer
- Manufacturer
- Geistlich-Pharma
Sources (1)
- FDA 510(k) K871773 24 fields · synced Sep 21, 2026