The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Tokuyama Curegrace.
| Device ID | K170549 |
| 510k Number | K170549 |
| Device Name: | TOKUYAMA CUREGRACE |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo, JP 110-0016 |
| Contact | Fumio Takahashi |
| Correspondent | Keith Barritt Fish & Richardson 1425 K Street, N.W., Suite 1100 Washington, DC 20005 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-24 |
| Decision Date | 2017-07-05 |
| Summary: | summary |