Equia® 452016
Equia® 452016 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K091106 on 17 Jun 2009 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D6584520161), 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 | NumberD6584520161 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091106 | Date17 Jun 2009 | StatusActive |
Official records
- FDA 510(k) database K091106
Across registries
- FDA 510(k) K091106 decided 17 Jun 2009 Active
- FDA GUDID UDI-DI D6584520161 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K091106
- Listed FDA GUDID D6584520161
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Equia®
- Generic name
- Glass ionomer dental cement
- Model / Ref / Catalog
- 452016
- Primary DI / UDI-DI
- D6584520161
- 510(k) Number
- FDA product code
- EMA
- GMDN term
- Glass ionomer dental cement
- Device class
- Class II
- Regulation number
- 872.3275
- GUDID distribution status
- In Commercial Distribution
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