The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Tokuso Rebase Mr. Bond.
| Device ID | K973245 |
| 510k Number | K973245 |
| Device Name: | TOKUSO REBASE MR. BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | TOKUYAMA AMERICA, INC. 1233 20TH., N.W. #700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli TOKUYAMA AMERICA, INC. 1233 20TH., N.W. #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 | 1997-08-29 |
| Decision Date | 1997-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190201334 | K973245 | 000 |