The following data is part of a premarket notification filed by Gc America, Inc with the FDA for Gradia Core.
| Device ID | K082171 |
| 510k Number | K082171 |
| Device Name: | GRADIA CORE |
| 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 | 2008-08-01 |
| Decision Date | 2008-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10386040008488 | K082171 | 000 |
| 10386040008471 | K082171 | 000 |
| 14548161296588 | K082171 | 000 |
| 14548161296571 | K082171 | 000 |
| 14548161296564 | K082171 | 000 |
| 14548161282970 | K082171 | 000 |