The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Palfique Inlay.
| Device ID | K913100 |
| 510k Number | K913100 |
| Device Name: | PALFIQUE INLAY |
| Classification | Material, Tooth Shade, Resin |
| Applicant | TOKUYAMA AMERICA, INC. C/O GRAHAM & JAMES 2000 M STREET, N.W., SUITE 700 Washington, DC 20036 |
| Contact | Emalee G Murphy |
| Correspondent | Emalee G Murphy TOKUYAMA AMERICA, INC. C/O GRAHAM & JAMES 2000 M STREET, N.W., SUITE 700 Washington, DC 20036 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-12 |
| Decision Date | 1991-10-02 |