The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Nanocomposite Restorative Kit.
| Device ID | K080480 |
| 510k Number | K080480 |
| Device Name: | NANOCOMPOSITE RESTORATIVE KIT |
| 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 | 2008-02-22 |
| Decision Date | 2008-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2207581 | K080480 | 000 |
| EDMG2208061 | K080480 | 000 |
| EDMG2208051 | K080480 | 000 |
| EDMG2208031 | K080480 | 000 |
| EDMG2208021 | K080480 | 000 |
| EDMG2208011 | K080480 | 000 |