Flashlite® CR1083
Flashlite® CR1083 is a Class II device made by Den-Mat Holdings, LLC, cleared under FDA 510(k) K073518 on 20 Dec 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI D813CR10830), 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 | NumberD813CR10830 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK073518 | Date20 Dec 2007 | StatusActive |
Official records
- FDA 510(k) database K073518
Across registries
- FDA 510(k) K073518 decided 20 Dec 2007 Active
- FDA GUDID UDI-DI D813CR10830 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K073518
- Listed FDA GUDID D813CR10830
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flashlite®
- Generic name
- Dental/surgical polymerization lamp
- Model / Ref / Catalog
- CR1083
- Primary DI / UDI-DI
- D813CR10830
- 510(k) Number
- FDA product code
- EBZ
- GMDN term
- Dental/surgical polymerization lamp
- Device class
- Class II
- Regulation number
- 872.6070
- GUDID distribution status
- In Commercial Distribution
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