The Light 405 402405
The Light 405 402405 is a dental/surgical polymerization lamp (FDA Class II; FDA product code EBZ, Activator, Ultraviolet, for Polymerization) made by Gc America Inc., cleared under FDA 510(k) K093751 on 24 Feb 2010 and listed in FDA GUDID since 15 Jul 2022 (UDI-DI 10386040012485), active as of 23 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 | Number10386040012485 | Date15 Jul 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093751 | Date24 Feb 2010 | StatusActive |
Official records
- AccessGUDID record 10386040012485
- FDA 510(k) database K093751
Across registries
- FDA 510(k) K093751 decided 24 Feb 2010 Active
- FDA GUDID UDI-DI 10386040012485 listed 15 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K093751
- Listed FDA GUDID 10386040012485
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- The Light 405
- Generic name
- Dental/surgical polymerization lamp
- Model / Ref / Catalog
- 402405
- Primary DI / UDI-DI
- 10386040012485
- 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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