The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Luxaform Plus.
| Device ID | K033227 |
| 510k Number | K033227 |
| Device Name: | LUXAFORM PLUS |
| 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 | 2003-10-06 |
| Decision Date | 2004-01-16 |
| Summary: | summary |