Ena Cem Hf CPCTUD4
by Micerium SpA
Ena Cem Hf CPCTUD4 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 EMICCPCTUD40), 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 | NumberEMICCPCTUD40 | 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 EMICCPCTUD40 listed 3 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K062355
- Listed FDA GUDID EMICCPCTUD40
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- Withdrawn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
- CPCTUD4
- Primary DI / UDI-DI
- EMICCPCTUD40
- 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
Similar devices in this category
Other devices filed under Dental composite resin.
- REFLECTYS A4 CP CPTYS-A4 by ITENA CLINICAL
- DENTOCORE BODY Cartridge A3 DCBODY-50 by ITENA CLINICAL
- x-tra base 1790 by VOCO GmbH
- BRILLIANT Flow 7101 by Coltène/Whaledent AG
- TPH Spectra ST flow 642527 by Dentsply De Trey GmbH
- Admira Fusion Flow 2822 by VOCO GmbH
- Simile N56BO by KERR CORPORATION
- Flow-It ALC N11K by KERR CORPORATION
- SYNERGY D6 8376 by Coltène/Whaledent AG
- DenFil Flow FR102-F000 by VERICOM CO., LTD.