The following data is part of a premarket notification filed by Kuraray Company, Ltd. with the FDA for Clearfil New Bond.
Device ID | K943167 |
510k Number | K943167 |
Device Name: | CLEARFIL NEW BOND |
Classification | Agent, Tooth Bonding, Resin |
Applicant | KURARAY COMPANY, LTD. 200 PARK AVE. New York, NY 10166 -3098 |
Contact | Kyoichiro Shibatani |
Correspondent | Kyoichiro Shibatani KURARAY COMPANY, LTD. 200 PARK AVE. New York, NY 10166 -3098 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-01 |
Decision Date | 1994-08-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLEARFIL NEW BOND 73546635 1428071 Live/Registered |
KURARAY CO., LTD. 1985-07-05 |