K251062
- 510(k) number
- K251062
- Device name
- 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 CH
- Product code
- NPL — Barrier, Animal Source, Intraoral
- Decision date
- 2025-08-14
- Date received
- 2025-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K251062.pdf
Official FDA record: K251062
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.