G-CEM LinkAce™ 004860
G-CEM LinkAce™ 004860 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K120243 on 27 Jun 2012 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470048601), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | NumberD0470048601 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120243 | Date27 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K120243
Across registries
- FDA 510(k) K120243 decided 27 Jun 2012 Active
- FDA GUDID UDI-DI D0470048601 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K120243
- Listed FDA GUDID D0470048601
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- G-CEM LinkAce™
- Generic name
- Dental composite resin
- Model / Ref / Catalog
- 004860
- Primary DI / UDI-DI
- D0470048601
- 510(k) Number
- FDA product code
- EMA
- GMDN term
- Dental composite resin
- Device class
- Class II
- Regulation number
- 872.3275
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code EMA (CEMENT, DENTAL).
- Provicol QM 1109 by VOCO GmbH
- VENEER CEMENT by Dentsply Intl.
- EMA LIV CENERA DENTAL CEMENT by Int'L Corp.
- PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER by Lustgarten Multi-Tech International, Inc.
- RESIMENT WITH FLUORIDE by J.L. Blosser, Inc.
- SELF-ADHESIVE RESIN CEMENT by Dentsply International
- FOREMOST DENTIN ADHESIVE by Foremost Dental Mfg., Inc.
- SILCOT COPAL CAVITY VARNISH by Specialites Septodont
- TRIONOMER by Pentron Clinical Technologies
- Bifix Veneer LC, Bifix Veneer Try-In by VOCO GmbH