Identifiers
- 510(k) Number
- K090216 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)
Collagen Dental Membrane IV is a sterile, non-pyrogenic, resorbable membrane matrix derived from bovine dermis (Type I and III collagen). It is a white, nonfriable, conformable membrane that is flexible and adapts to the contours of the defect site.
The device is used in oral surgery by dentists and oral surgeons to facilitate guided bone and tissue regeneration. Collagen Dental Membrane IV is supplied sterile, non-pyrogenic, in various sizes, and is intended for single use only. It has FDA 510(k) clearance with product code NPL.
Frequently asked questions
What is Collagen Dental Membrane IV used for?
Collagen Dental Membrane IV is used in oral surgery by dentists and oral surgeons to facilitate guided bone and tissue regeneration. It serves as a barrier membrane at the defect site to promote proper healing and tissue growth.
How is Collagen Dental Membrane IV supplied?
The membrane is supplied sterile and non-pyrogenic in various sizes to accommodate different clinical needs. Each unit is individually packaged and intended for single use only to ensure sterility and prevent cross-contamination.
What is the composition and characteristics of Collagen Dental Membrane IV?
Collagen Dental Membrane IV is derived from bovine dermis, containing Type I and III collagen. It appears as a white, nonfriable, conformable membrane that is flexible and adapts well to the contours of the defect site, making it easy to handle during surgical procedures.
What is the regulatory status of Collagen Dental Membrane IV?
Collagen Dental Membrane IV has FDA 510(k) clearance with product code NPL, classified as a Class II device. It received clearance on September 18, 2009, with the K number K090216, indicating it is substantially equivalent to predicate devices for its intended 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: K090216 FDA 510 (k) - COLLAGEN DENTAL MEMBRANE IV, COLLAGEN DENTAL MEMBRANE IV (K090216) — FDA 510(k) | Innolitics, PDF IKoqoa lb - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090216 | Class II | Active |
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Manufacturer
- Manufacturer
- Collagen Matrix, Inc.
Sources (1)
- FDA 510(k) K090216 24 fields · synced Sep 24, 2026