G-aenial™ 004212
G-aenial™ 004212 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 14548161323291), 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 | Number14548161323291 | Date5 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091388 | Date22 Jul 2009 | StatusActive |
Official records
- AccessGUDID record 14548161323291
- FDA 510(k) database K091388
Across registries
- FDA 510(k) K091388 decided 22 Jul 2009 Active
- FDA GUDID UDI-DI 14548161323291 listed 5 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K091388
- Listed FDA GUDID 14548161323291
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- Withdrawn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
- 004212
- Primary DI / UDI-DI
- 14548161323291
- 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
Similar devices in this category
Other devices filed under Dental composite resin.
- Prime-Core DC Automix Core Build Up Material 003-061 by PRIME DENTAL
- Flow-It ALC N11G by KERR CORPORATION
- Artiste N36AD by KERR CORPORATION
- BRILLIANT EverGlow 60021841 by Coltène/Whaledent AG
- Vittra APS Unique Flow 4000055624 by Dentscare Ltda
- edelweiss Enamel Flowable Composite 13770 by EDELWEISS DENTISTRY PRODUCTS GMBH
- Ena HRI ® EHTSF1 by MICERIUM SPA
- Nexcomp flow B2 9251 by Meta Biomed Co., Ltd.
- GrandioSO x-tra by VOCO GmbH
- BRILLIANT Flow 7110 by Coltène/Whaledent AG