Tempsmart™ 009400
Tempsmart™ 009400 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K141562 on 5 Sep 2014 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470094001), 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 | NumberD0470094001 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141562 | Date5 Sep 2014 | StatusActive |
Official records
- FDA 510(k) database K141562
Across registries
- FDA 510(k) K141562 decided 5 Sep 2014 Active
- FDA GUDID UDI-DI D0470094001 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K141562
- Listed FDA GUDID D0470094001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tempsmart™
- Generic name
- Temporary dental crown/bridge resin
- Model / Ref / Catalog
- 009400
- Primary DI / UDI-DI
- D0470094001
- 510(k) Number
- FDA product code
- EBG
- GMDN term
- Temporary dental crown/bridge resin
- Device class
- Class II
- Regulation number
- 872.3770
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 10 Milliliter
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