Ena Cem Hf CPCTUD2
by Micerium SpA
Ena Cem Hf CPCTUD2 is a Class II device made by Micerium SpA, cleared under FDA 510(k) K062355 on 27 Dec 2006 and listed in FDA GUDID since 3 Apr 2025 (UDI-DI EMICCPCTUD20), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberEMICCPCTUD20 | Date3 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK062355 | Date27 Dec 2006 | StatusActive |
Official records
- FDA 510(k) database K062355
Across registries
- FDA 510(k) K062355 decided 27 Dec 2006 Active
- FDA GUDID UDI-DI EMICCPCTUD20 listed 3 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K062355
- Listed FDA GUDID EMICCPCTUD20
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ena Cem Hf
- Generic name
- Dental composite resin
- Model / Ref / Catalog
- CPCTUD2
- Primary DI / UDI-DI
- EMICCPCTUD20
- 510(k) Number
- FDA product code
- EBF
- GMDN term
- Dental composite resin
- Device class
- Class II
- Regulation number
- 872.3690
- GUDID distribution status
- In Commercial Distribution
- Size
- Weight — 7 Gram
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