The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Sa Cement.
Device ID | K081583 |
510k Number | K081583 |
Device Name: | CLEARFIL SA CEMENT |
Classification | Cement, Dental |
Applicant | KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York, NY 10022 |
Contact | Koji Nishida |
Correspondent | Koji Nishida KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York, NY 10022 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-05 |
Decision Date | 2008-07-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLEARFIL SA CEMENT 76680078 3526144 Dead/Cancelled |
KURARAY CO., LTD. 2007-07-30 |