The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Tempocem.
Device ID | K110759 |
510k Number | K110759 |
Device Name: | TEMPOCEM |
Classification | Zinc Oxide Eugenol |
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 | EMB |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-18 |
Decision Date | 2011-06-10 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TEMPOCEM 75106484 2155450 Live/Registered |
MUHLBAUER TECHNOLOGY GMBH 1996-05-20 |