Gradia® 002296
Gradia® 002296 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K042348 on 18 Nov 2004 and listed in FDA GUDID since 5 Aug 2022 (UDI-DI 14548161075534), 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 | Number14548161075534 | Date5 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042348 | Date18 Nov 2004 | StatusActive |
Official records
- AccessGUDID record 14548161075534
- FDA 510(k) database K042348
Across registries
- FDA 510(k) K042348 decided 18 Nov 2004 Active
- FDA GUDID UDI-DI 14548161075534 listed 5 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K042348
- Listed FDA GUDID 14548161075534
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gradia®
- Generic name
- Dental composite resin
- Model / Ref / Catalog
- 002296
- Primary DI / UDI-DI
- 14548161075534
- 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
- Weight — 1.3 Gram
Similar devices in this category
Other devices filed under Dental composite resin.
- Ezfil B3 9423 by Meta Biomed Co., Ltd.
- Fibrafill® CUBE S F-001 by ADM, a.s.
- Grandio Flow Try-In by VOCO GmbH
- REFLECTYS A3 CP CPTYS-A3 by ITENA CLINICAL
- Simile N56AS by KERR CORPORATION
- TPH Spectra ST flow 642521 by Dentsply De Trey GmbH
- SoloCem 60019922 by Coltène/Whaledent AG
- Admira Flow 2486 by VOCO GmbH
- DenFil DF205-RB33 by VERICOM CO., LTD.
- REFLECTYS B2 CP CPTYS-B2 by ITENA CLINICAL