The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Tempocem Clear.
| Device ID | K160443 |
| 510k Number | K160443 |
| Device Name: | TempoCem Clear |
| Classification | Cement, Dental |
| Applicant | DMG USA, INC. 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 |
| Contact | Gordon Craig |
| Correspondent | Pam Papineau DELPHI MEDICAL DEVICE CONSULTING, INC. 5 WHITCOMB AVE Ayer, MA 01432 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-17 |
| Decision Date | 2016-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2132008 | K160443 | 000 |