The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Tokuyama Rebase Ii.
| Device ID | K022641 |
| 510k Number | K022641 |
| Device Name: | TOKUYAMA REBASE II |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-08 |
| Decision Date | 2002-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190205639 | K022641 | 000 |
| 04548190205622 | K022641 | 000 |
| 04548190205462 | K022641 | 000 |
| 04548190205066 | K022641 | 000 |
| 04548190201716 | K022641 | 000 |
| 04548190201723 | K022641 | 000 |