Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Geistlich Pharma AG. It received FDA 510(k) clearance on 2025-11-25 under approval 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. It is manufactured by Geistlich Pharma AG. The 510(k) number is K252253.

When was Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® approved by the FDA?

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

What company makes Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®?

Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® is manufactured by Geistlich Pharma AG.

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 Devices by Geistlich Pharma AG

K171050Geistlich Fibro-Gide K171842Geistlich Wound Matrix K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed K182838Geistlich Derma-Gide K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal K190754Orthoss(R)

View all 21 devices →

Related Devices (Code: NPL)

K160281OSSIX PLUSDatum Dental, Ltd. K153549OSSIX VOLUMAXDatum Dental, Ltd. K160474DSM Biomedical Porcine Pericardium Dental MembraneKensey Nash Corporation Dba Dsm Biomedical K171050Geistlich Fibro-GideGeistlich Pharma AG K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG K161762DynaMatrix/Dynamatrix PlusCook Biotech Incorporated

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.

↑