TOKUYAMA UNIVERSAL BOND
Agent, Tooth Bonding, Resin
Tokuyama Dental Corporation
The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Tokuyama Universal Bond.
Pre-market Notification Details
| Device ID | K171226 |
| 510k Number | K171226 |
| Device Name: | TOKUYAMA UNIVERSAL BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo, JP 110-0016 |
| Contact | Fumia Takahashi |
| Correspondent | Keith Barritt Fish & Richardson 901 15th Street, N.W., Suite 700 Washington, DC 20005 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-26 |
| Decision Date | 2017-11-28 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190152186 | K171226 | 000 |
| 04548190152131 | K171226 | 000 |
| 04548190152032 | K171226 | 000 |
| 04548190152094 | K171226 | 000 |
Trademark Results [TOKUYAMA UNIVERSAL BOND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOKUYAMA UNIVERSAL BOND 79191239 5135162 Live/Registered |
TOKUYAMA CORPORATION 2016-04-13 |
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