The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Gc Acrylic Primer.
| Device ID | K180917 |
| 510k Number | K180917 |
| Device Name: | GC Acrylic Primer |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-09 |
| Decision Date | 2018-11-20 |
| Summary: | summary |