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 |