The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Luxacore/luxacore Dual.
| Device ID | K012307 |
| 510k Number | K012307 |
| Device Name: | LUXACORE/LUXACORE DUAL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2133368 | K012307 | 000 |
| EDMG2120128 | K012307 | 000 |
| EDMG2120331 | K012307 | 000 |
| EDMG2120388 | K012307 | 000 |
| EDMG2120398 | K012307 | 000 |
| EDMG2120581 | K012307 | 000 |
| EDMG2120648 | K012307 | 000 |
| EDMG2121268 | K012307 | 000 |
| EDMG2121271 | K012307 | 000 |
| EDMG2133308 | K012307 | 000 |
| EDMG2133318 | K012307 | 000 |
| EDMG2133328 | K012307 | 000 |
| EDMG2133348 | K012307 | 000 |
| EDMG2133358 | K012307 | 000 |
| EDMG2120118 | K012307 | 000 |