FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
K Number: K171643
·
Decision Oct 30, 2017
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
56
Applicant Total
27
Review Days
150
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Basic Information
- Device Name
- Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
- K Number
- K171643
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Geistlich Pharma AG
- Date Received
- June 2, 2017
- Decision Date
- October 30, 2017
- Product Code
- NPL
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | FDA class 2 | Dental |
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Other Clearances by Geistlich Pharma AG
| K Number | Device Name | ||
|---|---|---|---|
| K260364 | Device 300419 Strip | Jun 2, 2026 | Substantially Equivalent |
| K260532 | Derma-Gide | Mar 19, 2026 | Substantially Equivalent |
| K251323 | Device 104 Particulate | Jan 22, 2026 | Substantially Equivalent |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Nov 25, 2025 | Substantially Equivalent |
| K251062 | 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 | Aug 14, 2025 | Substantially Equivalent |
| K251556 | Device 300423 Granules | Jul 17, 2025 | Substantially Equivalent |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Jul 11, 2025 | Substantially Equivalent |
| K251613 | SwissGraft X | Jun 26, 2025 | Substantially Equivalent |
| K250833 | SwissMembrane X; SwissMembrane X Socket | Apr 15, 2025 | Substantially Equivalent |
| K242510 | Geistlich Bio-Flow® | Mar 7, 2025 | Substantially Equivalent |