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Zimmer One Piece Implant, 3.7mm And 4.7mm, Models Zop37s10, 11, 13, 16 +3 more …
FDA 510(k)Class II (US FDA 510(k))
510(k) K063523
Identifiers
- 510(k) Number
- K063523 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
- Models / Variants
- Zop37a10, 11, 13, 16 FDA 510(k)Zop47s10, 11, 13, 16 FDA 510(k)Zop4 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)
Zimmer One Piece Implant, 3.7mm And 4.7mm, Models Zop37s10, 11, 13, 16 +3 more … by Zimmer Dental Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 models
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 | K063523 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Dental Inc.
- FDA Applicant
- Zimmer Dental, Inc.
Sources (1)
- FDA 510(k) K063523 24 fields · synced Jun 18, 2026