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Geistlich Fibro-Gide

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171050

by Geistlich Pharma AG

Identifiers

510(k) Number
K171050 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 Fibro-Gide is a porcine, porous, resorbable and volume-stable collagen matrix, specifically designed for soft-tissue regeneration. It is a barrier, animal source, intraoral device classified as Class II under FDA regulation 872.3930.

The device is supplied sterile and intended for single-use in dental applications. It has received FDA 510(k) clearance (K171050) as substantially equivalent to a predicate device, with product code NPL and advisory committee designation DE (Dental).

Frequently asked questions

What is Geistlich Fibro-Gide used for?

Geistlich Fibro-Gide is specifically designed for soft-tissue regeneration in dental applications, acting as a barrier to support tissue healing and regeneration in intraoral procedures.

Is Geistlich Fibro-Gide sterile and for single-use only?

Yes, Geistlich Fibro-Gide is supplied sterile and intended for single-use in dental applications, ensuring patient safety and eliminating the need for reprocessing or reuse.

What type of material is Geistlich Fibro-Gide made from?

Geistlich Fibro-Gide is a porcine-derived, porous, resorbable, and volume-stable collagen matrix, sourced from animal tissue and engineered for biocompatibility in soft-tissue repair.

How is Geistlich Fibro-Gide classified and regulated?

Geistlich Fibro-Gide is classified as a Class II medical device under FDA regulation 872.3930, with product code NPL, and received FDA 510(k) clearance (K171050) as substantially equivalent to a predicate device.

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 Fibro-Gide® - Geistlich Pharma AG, Regenerative Biomaterialien für die Zahnmedizin - Geistlich Pharma AG, Fibro-Gide - Geistlich Pharma AG, Geistlich Pharma International - Geistlich Pharma AG, Shop Geistlich Fibro-Gide® - 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) K171050 24 fields · synced Sep 27, 2026