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FDA 510(k)

Geistlich Mucograft®, Geistlich Mucograft® Seal

K-Number: K210280 · 2021-03-03

ApplicantGeistlich Pharma AG
Decision Date2021-03-03
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Geistlich Mucograft®, Geistlich Mucograft® Seal 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 2021-03-03 under 510(k) number K210280. 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 Mucograft®, Geistlich Mucograft® Seal is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Geistlich Pharma AG. The 510(k) number is K210280.

When did Geistlich Mucograft®, Geistlich Mucograft® Seal receive FDA 510(k) clearance?

Geistlich Mucograft®, Geistlich Mucograft® Seal received FDA 510(k) clearance on 2021-03-03, under 510(k) number K210280.

Who is the listed applicant for Geistlich Mucograft®, Geistlich Mucograft® Seal?

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?

The FDA product code for Geistlich Mucograft®, Geistlich Mucograft® Seal 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 ParticulateK252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®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 PackK251556Device 300423 Granules

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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.K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AGK251062Geistlich 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.

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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