The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Tokuyama Rebase Iii.
| Device ID | K190940 |
| 510k Number | K190940 |
| Device Name: | Tokuyama Rebase III |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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. 1001 Maine Ave., SW, Suite 1000 Washington, DC 20024 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-10 |
| Decision Date | 2019-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190206636 | K190940 | 000 |
| 04548190206629 | K190940 | 000 |
| 04548190206612 | K190940 | 000 |
| 04548190206605 | K190940 | 000 |