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Tapered Screw-Vent Implant, 4.1mm, Models: Tsv4b8, B10, B11, B13 And B16, Tsv4h…
FDA 510(k)Class II (US FDA 510(k))
510(k) K072589
Identifiers
- 510(k) Number
- K072589 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)
Tapered Screw-Vent Implant, 4.1mm, Models: Tsv4b8, B10, B11, B13 And B16, Tsv4h… by Zimmer Dental Inc. — Class II — FDA_510K — listed in FDA 510(k)
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 | K072589 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Dental Inc.
- FDA Applicant
- Zimmer Dental, Inc.
Sources (1)
- FDA 510(k) K072589 24 fields · synced Jun 19, 2026