Collagen Periodontal Membrane
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K003339 FDA 510(k)
- FDA Product Code
- NPL 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 Collagen Periodontal Membrane is an intraoral barrier device derived from an animal source. It is designed for use in dental procedures to serve as a barrier membrane.
This device is regulated under FDA 510(k) number K003339 and is classified as a dental barrier. It is intended for use by dental and periodontal surgeons.
Frequently asked questions
What is the primary purpose of the Collagen Periodontal Membrane?
This device is designed for use in dental procedures to serve as an intraoral barrier membrane. It is intended to be used by dental and periodontal surgeons during clinical interventions.
What is the source material for this barrier device?
The Collagen Periodontal Membrane is derived from an animal source. It is classified as a dental barrier under regulation number 872.3930.
How is this device regulated?
The device is regulated by the FDA under 510(k) number K003339. It was cleared through the traditional 510(k) pathway as being substantially equivalent to existing devices.
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: COLLAGEN PERIODONTAL MEMBRANE (K003339) — FDA 510(k) | Innolitics, PDF CMI_Dental Brochure - Regenity, Collagen - Wikipedia, COLLAGEN PERIODONTAL MEMBRANE 510 (k) K003339 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003339 | Class II | Active |
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Manufacturer
- Manufacturer
- Collagen Matrix, Inc.
Sources (1)
- FDA 510(k) K003339 24 fields · synced Sep 23, 2026