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Geistlich Mucograft® /Geistlich Mucograft® Seal +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252253

by Geistlich Pharma AG

Identifiers

510(k) Number
K252253 FDA 510(k)
FDA Product Code
NPL FDA 510(k)
Models / Variants
Geistlich Mucograft® /Geistlich Mucograft® Seal FDA 510(k)
Geistlich Fibro-Gide® 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, Geistlich Mucograft Seal, and Geistlich Fibro-Gide are animal-source barrier devices used in intraoral dental procedures. Geistlich Mucograft is a collagen matrix intended for soft-tissue regeneration, including the gain of keratinized tissue and recession coverage, serving as an alternative to autologous soft-tissue grafts. Geistlich Mucograft Seal is designed to seal the socket and stabilize the blood clot, supporting soft tissue healing and vascularization. Geistlich Fibro-Gide is part of the same product line and is used in similar regenerative contexts within the oral cavity.

These devices are supplied by Geistlich Pharma AG and are regulated under FDA 510(k) clearance with the product code NPL, classified as Class II devices under regulation 872.3930. They are intended for single use in dental settings and are provided sterile. The devices are not evaluated for MRI safety, and no specific storage conditions beyond standard medical device handling are indicated. Their use is restricted to professional dental practice, and they are authorized for distribution in accordance with the manufacturer’s regulatory filings.

Frequently asked questions

What are Geistlich Mucograft, Mucograft Seal, and Fibro-Gide used for in dental procedures?

These are animal-source barrier devices used for soft-tissue regeneration in dental procedures. Geistlich Mucograft helps gain keratinized tissue and cover recession as an alternative to autologous grafts. Mucograft Seal stabilizes blood clots in sockets to support healing, while Fibro-Gide is used for similar regenerative purposes in the oral cavity.

How are these devices supplied and what is their sterility status?

Geistlich Mucograft, Mucograft Seal, and Fibro-Gide are supplied by Geistlich Pharma AG and are provided sterile. They are intended for single use in dental settings and should be handled according to standard medical device protocols to maintain sterility.

What regulatory status do these devices have?

These devices are regulated under FDA 510(k) clearance with product code NPL, classified as Class II devices under regulation 872.3930. They have received traditional clearance and are substantially equivalent to predicate devices, with authorization for distribution in accordance with the manufacturer's regulatory filings.

Are there any specific storage conditions required for these devices?

No specific storage conditions beyond standard medical device handling are indicated for these products. They should be stored according to general medical device guidelines to maintain their integrity until 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 Mucograft® Seal - Geistlich Pharma AG, Geistlich Mucograft® - Geistlich Pharma AG, Geistlich Mucograft®- Redefining the Soft Tissue Matrix - Geistlich, Geistlich Mucograft® Product Support - Geistlich

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Geistlich Pharma AG

Sources (1)

  • FDA 510(k) K252253 24 fields · synced Sep 24, 2026