ESTECEM
Cement, Dental
TOKUYAMA DENTAL CORPORATION
The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Estecem.
Pre-market Notification Details
| Device ID | K150727 |
| 510k Number | K150727 |
| Device Name: | ESTECEM |
| Classification | Cement, Dental |
| Applicant | TOKUYAMA DENTAL CORPORATION 38-9 TAITO 1-CHOME, TAITO-KU Tokyo, JP 110-0016 |
| Contact | Fumio Takahashi |
| Correspondent | Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-20 |
| Decision Date | 2015-06-17 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190161881 | K150727 | 000 |
| 04548190161782 | K150727 | 000 |
| 04548190161683 | K150727 | 000 |
| 04548190161584 | K150727 | 000 |
| 04548190161485 | K150727 | 000 |
Trademark Results [ESTECEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESTECEM 77238260 not registered Dead/Abandoned |
Tokuyama Corporation 2007-07-25 |
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