The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for G-cem Linkforce, Dual Cure Activator, Try-in Paste, Multi Primer.
| Device ID | K153231 |
| 510k Number | K153231 |
| Device Name: | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer |
| Classification | Cement, Dental |
| Applicant | GC AMERICA, INC. 3737 W. 127TH ST. Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA, INC. 3737 W. 127TH ST. 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 | 2015-11-09 |
| Decision Date | 2016-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0470095514 | K153231 | 000 |
| 44548161297364 | K153231 | 000 |
| 44548161297517 | K153231 | 000 |
| 44548161321830 | K153231 | 000 |
| 44548161321847 | K153231 | 000 |
| 44548161321854 | K153231 | 000 |
| 44548161321861 | K153231 | 000 |
| 44548161321878 | K153231 | 000 |
| 44548161321885 | K153231 | 000 |
| 44548161321892 | K153231 | 000 |
| 14548161292474 | K153231 | 000 |
| 14548161292481 | K153231 | 000 |
| 14548161292498 | K153231 | 000 |
| 14548161292504 | K153231 | 000 |
| D0470095484 | K153231 | 000 |
| D0470095494 | K153231 | 000 |
| D0470095504 | K153231 | 000 |
| D0470095524 | K153231 | 000 |