The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Majesty Esthetic.
| Device ID | K061860 |
| 510k Number | K061860 |
| Device Name: | CLEARFIL MAJESTY ESTHETIC |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. New York, NY 10022 |
| Contact | Koji Nishida |
| Correspondent | Koji Nishida KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. 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 | 2006-06-30 |
| Decision Date | 2006-09-18 |
| Summary: | summary |