Bio-Gide Resorbable Bilayer Membrane
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K960724 FDA 510(k)
- FDA Product Code
- NPK 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
- SESE Substantially Equivalent FDA 510(k)
The Bio-Gide Resorbable Bilayer Membrane is an intraoral synthetic barrier device. It is designed to function as a membrane to support bone regeneration and tissue integration.
This device is regulated under FDA 510(k) clearance K960724. It is classified as a Class 2 dental device under regulation number 872.3930.
Frequently asked questions
What is the primary function of the Bio-Gide Resorbable Bilayer Membrane?
This device is an intraoral synthetic barrier designed to support bone regeneration and facilitate tissue integration during dental procedures.
How is the Bio-Gide Resorbable Bilayer Membrane regulated?
The device is classified as a Class 2 dental device under regulation number 872.3930 and has received FDA 510(k) clearance under K960724.
What is the medical specialty associated with this device?
The Bio-Gide Resorbable Bilayer Membrane is categorized under the dental medical specialty, as it is specifically designed for intraoral use.
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: Geistlich Bio-Gide® - The Collagen Membrane Expert - Geistlich, Geistlich Bio-Gide - Geistlich Pharma AG, PDF Geistlich Bio-Gide®
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K960724 | Class II | Active |
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Manufacturer
- Manufacturer
- Geistlich-Pharma
Sources (1)
- FDA 510(k) K960724 24 fields · synced Sep 27, 2026