Gradia® 003653
Gradia® 003653 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K082171 on 30 Oct 2008 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470036531), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | NumberD0470036531 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082171 | Date30 Oct 2008 | StatusActive |
Official records
- FDA 510(k) database K082171
Across registries
- FDA 510(k) K082171 decided 30 Oct 2008 Active
- FDA GUDID UDI-DI D0470036531 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K082171
- Listed FDA GUDID D0470036531
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- Withdrawn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
- 003653
- Description
- GRADIA® CORE SE Bond Liquid A , 3 mL
- Primary DI / UDI-DI
- D0470036531
- 510(k) Number
- FDA product code
- EBF
- GMDN term
- Dental composite resin
- Device class
- Class II
- Regulation number
- 872.3690
- GUDID distribution status
- Not in Commercial Distribution
- Size
- Total Volume — 3 Milliliter
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