The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Gradia Plus.
| Device ID | K153325 |
| 510k Number | K153325 |
| Device Name: | Gradia Plus |
| Classification | Material, Tooth Shade, 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-19 |
| Decision Date | 2016-07-12 |
| Summary: | summary |