Geistlich Mucograft®, Geistlich Mucograft® Seal
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210280 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)
Geistlich Mucograft and Geistlich Mucograft Seal are animal source intraoral barrier devices composed of porcine collagen. These matrices are designed for soft-tissue regeneration in the oral cavity, including gaining keratinized tissue and recession coverage.
The device is supplied as a regenerative biomaterial and serves as an alternative to autologous soft-tissue grafts. It has received FDA 510(k) clearance for use in dental procedures.
Frequently asked questions
What are Geistlich Mucograft and Mucograft Seal used for?
These devices are intraoral barrier matrices designed for soft-tissue regeneration within the oral cavity. They are specifically indicated for procedures such as gaining keratinized tissue and providing recession coverage.
What is the composition of these barrier devices?
Geistlich Mucograft and Geistlich Mucograft Seal are composed of porcine collagen. They serve as an animal-source regenerative biomaterial intended to act as an alternative to autologous soft-tissue grafts.
What is the regulatory status of these devices?
These devices have received FDA 510(k) clearance for use in dental procedures. They are classified as an intraoral, animal-source barrier under regulation number 872.3930.
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 Mucograft® - Geistlich Pharma AG, Regenerative Biomaterialien für die Zahnmedizin - Geistlich Pharma AG, Geistlich Mucograft®- Redefining the Soft Tissue Matrix - Geistlich
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210280 | Class II | Active |
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Manufacturer
- Manufacturer
- Geistlich Pharma AG
Sources (1)
- FDA 510(k) K210280 24 fields · synced Sep 23, 2026