Geistlich Bio-Gide +6 more— 510(k) K251062

Substantially Equivalent

Geistlich Pharma AG

FDA 510(k) clearance K251062 for Geistlich Bio-Gide +6 more, Substantially Equivalent on 2025-08-14. Applicant: Geistlich Pharma AG. Device class: 2.

Clearance details

Device name as filed
Geistlich 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 Pack
Applicant
Geistlich Pharma AG
Product code
Code NPL
Device class
Class 2
Regulation
21 CFR 872.3930
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wolhusen, CH
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