The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Tokuyama Soft Relining.
| Device ID | K953589 |
| 510k Number | K953589 |
| Device Name: | TOKUYAMA SOFT RELINING |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | TOKUYAMA AMERICA, INC. C/O GRAHAM & JAMES 2000 M STREET, N.W., SUITE 700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli TOKUYAMA AMERICA, INC. C/O GRAHAM & JAMES 2000 M STREET, N.W., 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 | 1995-08-01 |
| Decision Date | 1996-01-18 |