GC Fuji TEMP LT™ 004253
GC Fuji TEMP LT™ 004253 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K101420 on 17 Sep 2010 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470042531), 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 | NumberD0470042531 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK101420 | Date17 Sep 2010 | StatusActive |
Official records
- FDA 510(k) database K101420
Across registries
- FDA 510(k) K101420 decided 17 Sep 2010 Active
- FDA GUDID UDI-DI D0470042531 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K101420
- Listed FDA GUDID D0470042531
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GC Fuji TEMP LT™
- Generic name
- Glass ionomer dental cement
- Model / Ref / Catalog
- 004253
- Primary DI / UDI-DI
- D0470042531
- 510(k) Number
- FDA product code
- EMA
- GMDN term
- Glass ionomer dental cement
- Device class
- Class II
- Regulation number
- 872.3275
- GUDID distribution status
- In Commercial Distribution
- Size
- Weight — 13.3 Gram
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