The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Palfique Estelite Lv.
| Device ID | K002863 |
| 510k Number | K002863 |
| Device Name: | PALFIQUE ESTELITE LV |
| Classification | Material, Tooth Shade, Resin |
| Applicant | TOKUYAMA AMERICA, INC. 2000 M ST. NW SUITE 700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli TOKUYAMA AMERICA, INC. 2000 M ST. NW 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 | 2000-09-13 |
| Decision Date | 2001-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190123247 | K002863 | 000 |
| 04548190123124 | K002863 | 000 |
| 04548190123131 | K002863 | 000 |
| 04548190123162 | K002863 | 000 |
| 04548190123179 | K002863 | 000 |
| 04548190123186 | K002863 | 000 |
| 04548190123216 | K002863 | 000 |
| 04548190123223 | K002863 | 000 |
| 04548190123230 | K002863 | 000 |
| 04548190123117 | K002863 | 000 |