The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Majesty Esthetic Plt.
| Device ID | K070325 |
| 510k Number | K070325 |
| Device Name: | CLEARFIL MAJESTY ESTHETIC PLT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York, NY 10022 |
| Contact | Koji Nishida |
| Correspondent | Koji Nishida KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York, NY 10022 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-05 |
| Decision Date | 2007-03-21 |
| Summary: | summary |