The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Gam-200.
| Device ID | K120243 |
| 510k Number | K120243 |
| Device Name: | GAM-200 |
| Classification | Cement, Dental |
| Applicant | GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-27 |
| Decision Date | 2012-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0470048601 | K120243 | 000 |
| D0470048591 | K120243 | 000 |
| D0470048581 | K120243 | 000 |
| D0470048571 | K120243 | 000 |