CLEARFIL TRI-S BOND
Agent, Tooth Bonding, Resin
KURARAY MEDICAL INC.
The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Tri-s Bond.
Pre-market Notification Details
| Device ID | K042913 |
| 510k Number | K042913 |
| Device Name: | CLEARFIL TRI-S BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. New York, NY 10022 |
| Contact | Satoshi Yamaguchi |
| Correspondent | Satoshi Yamaguchi KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. New York, NY 10022 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-21 |
| Decision Date | 2004-11-26 |
Trademark Results [CLEARFIL TRI-S BOND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARFIL TRI-S BOND 76610059 3177482 Live/Registered |
KURARAY CO., LTD. 2004-09-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.