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 |