The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Tokuyama Sofreliner Tough.
| Device ID | K030663 |
| 510k Number | K030663 |
| Device Name: | TOKUYAMA SOFRELINER TOUGH |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | TOKUYAMA DENTAL CORPORATION 2000 M ST. N.W. 7TH FLOOR Washington, DC 20036 -3307 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli TOKUYAMA DENTAL CORPORATION 2000 M ST. N.W. 7TH FLOOR Washington, DC 20036 -3307 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-03 |
| Decision Date | 2003-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190233564 | K030663 | 000 |
| 04548190233519 | K030663 | 000 |