FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
SwissGraft X
K Number: K251613
·
Decision Jun 26, 2025
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
39
Applicant Total
27
Review Days
30
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Basic Information
- Device Name
- SwissGraft X
- K Number
- K251613
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Geistlich Pharma AG
- Date Received
- May 27, 2025
- Decision Date
- June 26, 2025
- Product Code
- NPM
- 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 |
|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | 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 |
| K250833 | SwissMembrane X; SwissMembrane X Socket | Apr 15, 2025 | Substantially Equivalent |
| K242510 | Geistlich Bio-Flow® | Mar 7, 2025 | Substantially Equivalent |
| K241802 | Device 300397 Putty | Nov 8, 2024 | Substantially Equivalent |