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Prevest Denpro Dental Cements (Micron Bioactive +4 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K200555
Identifiers
- 510(k) Number
- K200555 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
- Models / Variants
- Micron Bioactive FDA 510(k)Micron Superior FDA 510(k)Micron Superior Capsules FDA 510(k)Micron Luting FDA 510(k)Micron Dentin Conditioner FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Prevest Denpro Dental Cements (Micron Bioactive +4 more) by Prevest Denpro Limited — Class II — FDA_510K — listed in FDA 510(k) — 5 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 | K200555 | Class II | Active |
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Manufacturer
- Manufacturer
- Prevest Denpro Limited
Sources (1)
- FDA 510(k) K200555 24 fields · synced Jun 18, 2026