The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Gradia Direct X.
| Device ID | K070190 |
| 510k Number | K070190 |
| Device Name: | GRADIA DIRECT X |
| Classification | Material, Tooth Shade, Resin |
| Applicant | GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803 |
| Contact | Terry L Joritz-lyons |
| Correspondent | Terry L Joritz-lyons GC AMERICA INC. 3737 WEST 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 | 2007-01-22 |
| Decision Date | 2007-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14548161322355 | K070190 | 000 |
| 14548161292221 | K070190 | 000 |
| 14548161292214 | K070190 | 000 |
| 14548161292207 | K070190 | 000 |
| 04548161292194 | K070190 | 000 |
| 04548161292187 | K070190 | 000 |
| 04548161292170 | K070190 | 000 |
| 04548161292163 | K070190 | 000 |
| 04548161292156 | K070190 | 000 |
| 04548161292026 | K070190 | 000 |
| 14548161282956 | K070190 | 000 |
| 14548161292238 | K070190 | 000 |
| 04548161322242 | K070190 | 000 |
| 14548161322348 | K070190 | 000 |
| 04548161322334 | K070190 | 000 |
| 04548161322327 | K070190 | 000 |
| 14548161322317 | K070190 | 000 |
| 14548161322300 | K070190 | 000 |
| 14548161322294 | K070190 | 000 |
| 14548161322287 | K070190 | 000 |
| 04548161322273 | K070190 | 000 |
| 04548161322266 | K070190 | 000 |
| 04548161322259 | K070190 | 000 |
| 14548161282949 | K070190 | 000 |