Gam-200
510(k) K120243
Gam-200 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K120243 on 27 Jun 2012, 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 | FDA 510(k)SESE | NumberK120243 | Date27 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K120243
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EMA
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K120243
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| G-CEM LinkAce™ 004857 | 004857 / 004857 | D0470048571 | — | No longer on the market |
| G-CEM LinkAce™ 004858 | 004858 / 004858 | D0470048581 | — | No longer on the market |
| G-CEM LinkAce™ 004859 | 004859 / 004859 | D0470048591 | — | No longer on the market |
| G-CEM LinkAce™ 004860 | 004860 / 004860 | D0470048601 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code EMA (Cement, Dental).
- CIMPAT S TEMPORARY DENTAL CEMENT by Specialites Septodont
- FIXOBRIDGE 3-CEMENT by ADVANCED HEALTHCARE LTD.
- CERCOM II CEMENT by DENALI CORPORATION
- Parkell Self-Adhesive Cement by PARKELL, INC.
- Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) by IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS.
- U-Cem Premium & MAZIC Cem by VERICOM CO., LTD.
- RESTORE-X by First Scientific Limited
- TNE 7760 by Temrex Corp.
- ZINC CEMENT by Adp Intl., Inc.
- FLOWABLE COMPOSITE by Dentsply Intl.