Gradia® 002290
Gradia® 002290 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 14548161075466), 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 | Number14548161075466 | Date5 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042348 | Date18 Nov 2004 | StatusActive |
Official records
- AccessGUDID record 14548161075466
- FDA 510(k) database K042348
Across registries
- FDA 510(k) K042348 decided 18 Nov 2004 Active
- FDA GUDID UDI-DI 14548161075466 listed 5 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K042348
- Listed FDA GUDID 14548161075466
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- Withdrawn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
- 002290
- Description
- GRADIA® DIRECT LoFlo - 2 syringes (1.3 g/0.8 mL per syringe) A2, & 4 tips
- Primary DI / UDI-DI
- 14548161075466
- 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
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