The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Gc Temp Print.
| Device ID | K193113 |
| 510k Number | K193113 |
| Device Name: | GC Temp Print |
| Classification | Crown And Bridge, Temporary, 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2020-07-09 |