The following data is part of a premarket notification filed by Kuraray America, Inc. with the FDA for Clearfil Majesty Flow.
| Device ID | K063593 |
| 510k Number | K063593 |
| Device Name: | CLEARFIL MAJESTY FLOW |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY AMERICA, INC. 600 LEXINGTON AVE. 26TH FLOOR New York, NY 10022 |
| Contact | Koji Nishida |
| Correspondent | Koji Nishida KURARAY AMERICA, INC. 600 LEXINGTON AVE. 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 | 2006-12-04 |
| Decision Date | 2007-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR02611KAS1 | K063593 | 000 |
| EKUR002610KA1 | K063593 | 000 |
| EKUR002611KA1 | K063593 | 000 |
| EKUR002612KA1 | K063593 | 000 |
| EKUR002613KA1 | K063593 | 000 |
| EKUR002615KA1 | K063593 | 000 |
| EKUR002616KA1 | K063593 | 000 |
| EKUR002618KA1 | K063593 | 000 |
| EKUR002619KA1 | K063593 | 000 |
| EKUR002620KA1 | K063593 | 000 |
| EKUR002621KA1 | K063593 | 000 |
| EKUR002632KA1 | K063593 | 000 |
| EKUR002635KA1 | K063593 | 000 |
| EKUR001015KA1 | K063593 | 000 |