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Geistlich Bio-Gide - Geistlich Bio-Gide® Compressed
FDA 510(k)Class II (US FDA 510(k))
510(k) K251062
Identifiers
- 510(k) Number
- K251062 FDA 510(k)
- FDA Product Code
- NPL FDA 510(k)
- Models / Variants
- Geistlich Bio-Gide FDA 510(k)Geistlich Bio-Gide® Shape FDA 510(k)Geistlich Bio-Gide® Compressed FDA 510(k)Geistlich Bio-Gide® Forte FDA 510(k)Geistlich Bio-Gide® Perio FDA 510(k)Geistlich Combi-Kit Collagen® FDA 510(k)Geistlich Perio-System Combi Pack FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3930 FDA 510(k)
- Regulation Number
- 872.3930 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Geistlich Bio-Gide - Geistlich Bio-Gide® Compressed by Geistlich Pharma AG — Class II — FDA_510K — listed in FDA 510(k) — 7 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251062 | Class II | Active |
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Manufacturer
- Manufacturer
- Geistlich Pharma AG
Sources (1)
- FDA 510(k) K251062 24 fields · synced Jun 18, 2026