The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Clearfil Majesty Ic.
| Device ID | K182430 |
| 510k Number | K182430 |
| Device Name: | CLEARFIL MAJESTY IC |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Kuraray Noritake Dental Inc. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku, JP 100-0004 |
| Contact | Yasujiro Ohara |
| Correspondent | Yasujiro Ohara Kuraray Noritake Dental Inc. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku, JP 100-0004 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-06 |
| Decision Date | 2019-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR004235KA1 | K182430 | 000 |
| EKUR003872KA1 | K182430 | 000 |
| EKUR003873KA1 | K182430 | 000 |
| EKUR003874KA1 | K182430 | 000 |
| EKUR003875KA1 | K182430 | 000 |
| EKUR003877KA1 | K182430 | 000 |
| EKUR003878KA1 | K182430 | 000 |
| EKUR003879KA1 | K182430 | 000 |
| EKUR003880KA1 | K182430 | 000 |
| EKUR003891KA1 | K182430 | 000 |
| EKUR003892KA1 | K182430 | 000 |
| EKUR004231KA1 | K182430 | 000 |
| EKUR004232KA1 | K182430 | 000 |
| EKUR004234KA1 | K182430 | 000 |
| EKUR003871KA1 | K182430 | 000 |