The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Tokuyama One-up-bond F.
| Device ID | K993917 |
| 510k Number | K993917 |
| Device Name: | TOKUYAMA ONE-UP-BOND F |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | TOKUYAMA AMERICA, INC. 2000 M ST. NW SUITE 700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli TOKUYAMA AMERICA, INC. 2000 M ST. NW SUITE 700 Washington, DC 20036 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-17 |
| Decision Date | 2000-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190147373 | K993917 | 000 |
| 04548190147366 | K993917 | 000 |
| 04548190147069 | K993917 | 000 |