Kalore™ 003621
Kalore™ 003621 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 5 Aug 2022 (UDI-DI 14548161291361), 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 | Number14548161291361 | Date5 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082434 | Date14 Nov 2008 | StatusActive |
Official records
- AccessGUDID record 14548161291361
- FDA 510(k) database K082434
Across registries
- FDA 510(k) K082434 decided 14 Nov 2008 Active
- FDA GUDID UDI-DI 14548161291361 listed 5 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K082434
- Listed FDA GUDID 14548161291361
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kalore™
- Generic name
- Dental composite resin
- Model / Ref / Catalog
- 003621
- Primary DI / UDI-DI
- 14548161291361
- 510(k) Number
- FDA product code
- EBF
- GMDN term
- Dental composite resin
- Device class
- Class II
- Regulation number
- 872.3690
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 0.16 Milliliter
Similar devices in this category
Other devices filed under Dental composite resin.
- REFLECTYS A4 CP CPTYS-A4 by ITENA CLINICAL
- DENTOCORE BODY Cartridge A3 DCBODY-50 by ITENA CLINICAL
- x-tra base 1790 by VOCO GmbH
- BRILLIANT Flow 7101 by Coltène/Whaledent AG
- TPH Spectra ST flow 642527 by Dentsply De Trey GmbH
- Admira Fusion Flow 2822 by VOCO GmbH
- Simile N56BO by KERR CORPORATION
- Flow-It ALC N11K by KERR CORPORATION
- SYNERGY D6 8376 by Coltène/Whaledent AG
- DenFil Flow FR102-F000 by VERICOM CO., LTD.