The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Tokuyama Universal Bond Ii.
| Device ID | K203760 |
| 510k Number | K203760 |
| Device Name: | Tokuyama Universal Bond II |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo, JP 110-0016 |
| Contact | Keith A. Barritt |
| Correspondent | Keith A. Barritt Fish & Richardson, P.C. 1000 Maine Avenue, S.W., Suite 1000 Washington, DC 20024 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-23 |
| Decision Date | 2021-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190153299 | K203760 | 000 |
| 04548190153206 | K203760 | 000 |
| 04548190153152 | K203760 | 000 |
| 04548190153107 | K203760 | 000 |