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FDA 510(k)

Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®

K-Number: K252253 · 2025-11-25

ApplicantGeistlich Pharma AG
Decision Date2025-11-25
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K252253. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®?

Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Geistlich Pharma AG. The 510(k) number is K252253.

When did Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® receive FDA 510(k) clearance?

Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252253.

Who is the listed applicant for Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®?

The FDA 510(k) record lists Geistlich Pharma AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®?

The FDA product code for Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® is NPL.

Other records listing Geistlich Pharma AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260364Device 300419 StripK260532Derma-GideK251323Device 104 ParticulateK251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackK251556Device 300423 GranulesK251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

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Related Devices (Code: NPL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242817Jason membraneBotiss Biomaterials GmbHK250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackGeistlich Pharma AGK250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AGK233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc.K231513Oral MatrixBeijing Biosis Healing Biolog Ical Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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