Cerec 6371830
Cerec 6371830 is a Class II device made by SIRONA Dental Systems GmbH, cleared under FDA 510(k) K111421 on 17 Feb 2012 (1 earlier submission) and listed in FDA GUDID since 10 Sep 2016 (UDI-DI E27663718300), 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 | NumberE27663718300 | Date10 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111421 | Date17 Feb 2012 | StatusActive |
Official records
- FDA 510(k) database K111421
- FDA 510(k) database K100152
Across registries
- FDA 510(k) K111421 decided 17 Feb 2012 Active
- FDA GUDID UDI-DI E27663718300 listed 10 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K100152
- Cleared FDA 510(k) K111421
- Listed FDA GUDID E27663718300
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cerec
- Generic name
- CAD/CAM software
- Model / reference
- 6371830
- Primary DI / UDI-DI
- E27663718300
- FDA product code
- NHA
- GMDN term
- CAD/CAM software
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
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