G-aenial™ 004215
G-aenial™ 004215 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K091388 on 22 Jul 2009 and listed in FDA GUDID since 5 Aug 2022 (UDI-DI 14548161323321), 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 | Number14548161323321 | Date5 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091388 | Date22 Jul 2009 | StatusActive |
Official records
- AccessGUDID record 14548161323321
- FDA 510(k) database K091388
Across registries
- FDA 510(k) K091388 decided 22 Jul 2009 Active
- FDA GUDID UDI-DI 14548161323321 listed 5 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K091388
- Listed FDA GUDID 14548161323321
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- G-aenial™
- Generic name
- Dental composite resin
- Model / Ref / Catalog
- 004215
- Primary DI / UDI-DI
- 14548161323321
- 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
- Total Volume — 2 Milliliter
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