Collagen Dental Mambrane - Porcine Type I Collagen
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110600 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 Dental Membrane is an animal-sourced intraoral barrier device composed of porcine Type I collagen. It is intended for use in oral surgical procedures as a resorbable material for placement in areas of dental implants, bone defects, or ridge reconstruction to aid in wound healing.
This device has received FDA 510(k) clearance. It is supplied as a resorbable membrane for clinical use in dental settings.
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 Dental Mambrane - Porcine Type I Collagen, Products & Services - Regenity, MatrixMem Regenerative Collagen Membrane - West Dental Supply, PDF CMI_Dental Brochure - Regenity
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110600 | Class II | Active |
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Manufacturer
- Manufacturer
- Collagen Matrix, Inc.
Sources (1)
- FDA 510(k) K110600 24 fields · synced Oct 6, 2026