The following data is part of a premarket notification filed by Kuraray Co. with the FDA for Clearfil Veneer Bond Kit.
Device ID | K900690 |
510k Number | K900690 |
Device Name: | CLEARFIL VENEER BOND KIT |
Classification | Material, Tooth Shade, Resin |
Applicant | KURARAY CO. 200 PARK AVE. New York, NY 10166 |
Contact | Shuji Kawai |
Correspondent | Shuji Kawai KURARAY CO. 200 PARK AVE. New York, NY 10166 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-13 |
Decision Date | 1990-04-13 |