Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®— 510(k) K252253

Name: FDA 510(k) clearance K252253
Creator: U.S. Food and Drug Administration
Published: 2025-11-25

Substantially Equivalent

Geistlich Pharma AG

FDA 510(k) clearance K252253 for Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®, Substantially Equivalent on 2025-11-25. Applicant: Geistlich Pharma AG. Device class: 2.

Clearance details

Applicant: Geistlich Pharma AG
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2025-07-21
Decision date: 2025-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wolhusen, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPL

view all

K242817 — Jason membrane2025-12-12
K250512 — Augmented Gingival Matrix2025-12-05
K251062 — Geistlich Bio-Gide +6 more2025-08-14
K250833 — SwissMembrane X; SwissMembrane X Socket2025-04-15
K233203 — Soft Tissue Augmentation Resorbable Matrix2024-05-01

More clearances from Geistlich Pharma AG

view all

K260364 — Device 300419 Strip2026-06-02
K260532 — Derma-Gide2026-03-19
K251323 — Device 104 Particulate2026-01-22
K251556 — Device 300423 Granules2025-07-17
K251786 — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®2025-07-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.