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Straumann Bone Level Tapered Implants
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
510(k) K153758
Identifiers
- 510(k) Number
- K153758 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Straumann Bone Level Tapered Implants by Institut Straumann AG — Class II — MDR, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K153758 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (2)
- FDA 510(k) K153758 24 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 18, 2026