The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gradia Direct Loflo.
| Device ID | K042348 |
| 510k Number | K042348 |
| Device Name: | GRADIA DIRECT LOFLO |
| Classification | Material, Tooth Shade, Resin |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry Joritz |
| Correspondent | Terry Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-08-30 |
| Decision Date | 2004-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14548161075558 | K042348 | 000 |
| 14548161075534 | K042348 | 000 |
| 14548161075510 | K042348 | 000 |
| 14548161075480 | K042348 | 000 |
| 14548161075473 | K042348 | 000 |
| 14548161075466 | K042348 | 000 |
| 14548161075459 | K042348 | 000 |