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Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set +4…
FDA 510(k)Class II (US FDA 510(k))
510(k) K213244
Identifiers
- 510(k) Number
- K213244 FDA 510(k)
- FDA Product Code
- ELW FDA 510(k)
- Models / Variants
- Accusil Light Body Regular and Fast Set FDA 510(k)Accusil Heavy Body Regular and Fast Set FDA 510(k)Accusil Monophase Regular and Fast Set FDA 510(k)Accusil Putty Regular and Fast Set FDA 510(k)Accusil Bite Registration FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3660 FDA 510(k)
- Regulation Number
- 872.3660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set +4… by Prevest Denpro Limited — Class II — FDA_510K — listed in FDA 510(k) — 5…
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 | K213244 | Class II | Active |
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Manufacturer
- Manufacturer
- Prevest Denpro Limited
Sources (1)
- FDA 510(k) K213244 24 fields · synced Jun 18, 2026