The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Palfique Estelite.
| Device ID | K980054 |
| 510k Number | K980054 |
| Device Name: | PALFIQUE ESTELITE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | TOKUYAMA AMERICA, INC. 1233 20TH., N.W. #700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli TOKUYAMA AMERICA, INC. 1233 20TH., N.W. #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 | 1998-01-06 |
| Decision Date | 1998-04-27 |
| Summary: | summary |