TEMPOCEM
Zinc Oxide Eugenol
DMG USA, INC.
The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Tempocem.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2121291 | K110759 | 000 |
| EDMG1103001 | K110759 | 000 |
Trademark Results [TEMPOCEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TEMPOCEM 75106484 2155450 Live/Registered |
MUHLBAUER TECHNOLOGY GMBH 1996-05-20 |
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