The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Luxaform.
| Device ID | K000951 |
| 510k Number | K000951 |
| Device Name: | LUXAFORM |
| Classification | Crown And Bridge, Temporary, 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-23 |
| Decision Date | 2000-04-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LUXAFORM 76176145 2826842 Dead/Cancelled |
ERNST MUHLBAUER GMBH & CO, KG 2000-12-05 |