Gradia® 001970
Gradia 001970 is a light-cured dental restorative composite resin (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Gc America Inc., cleared under FDA 510(k) K023814 on 30 Jan 2003 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470019701), 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 | NumberD0470019701 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023814 | Date30 Jan 2003 | StatusActive |
Official records
- FDA 510(k) database K023814
Across registries
- FDA 510(k) K023814 decided 30 Jan 2003 Active
- FDA GUDID UDI-DI D0470019701 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K023814
- Listed FDA GUDID D0470019701
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Gradia®
- Generic name
- Light-cured dental restorative composite resin
- Model / Ref / Catalog
- 001970
- Description
- GRADIA® DIRECT Unitips: 20 tips 0.16 mL A3.5
- Primary DI / UDI-DI
- D0470019701
- 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 — 0.16 Milliliter
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