Kalore™ 003578
Kalore™ 003578 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K082434 on 14 Nov 2008 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470035781), 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 | NumberD0470035781 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082434 | Date14 Nov 2008 | StatusActive |
Official records
- FDA 510(k) database K082434
Across registries
- FDA 510(k) K082434 decided 14 Nov 2008 Active
- FDA GUDID UDI-DI D0470035781 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K082434
- Listed FDA GUDID D0470035781
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kalore™
- Generic name
- Light-cured dental restorative composite resin
- Model / Ref / Catalog
- 003578
- Primary DI / UDI-DI
- D0470035781
- 510(k) Number
- FDA product code
- EBF
- GMDN term
- Light-cured dental restorative composite resin
- Device class
- Class II
- Regulation number
- 872.3690
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 2 Milliliter
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