CLEARFIL PROTECT 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 Protect Bond.
Pre-market Notification Details
| Device ID | K033938 |
| 510k Number | K033938 |
| Device Name: | CLEARFIL PROTECT BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY MEDICAL INC. 1425 K STREET, N.W. 11TH FLOOR Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt KURARAY MEDICAL INC. 1425 K STREET, N.W. 11TH FLOOR Washington, DC 20005 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-12-19 |
| Decision Date | 2004-01-29 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR002887KA1 | K033938 | 000 |
| EKUR002886KA1 | K033938 | 000 |
| EKUR002882KA1 | K033938 | 000 |
| EKUR002881KA1 | K033938 | 000 |
| EKUR002875KA1 | K033938 | 000 |
| EKUR002872KA1 | K033938 | 000 |
| EKUR002870KA1 | K033938 | 000 |
Trademark Results [CLEARFIL PROTECT BOND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARFIL PROTECT BOND 78286615 2961150 Dead/Cancelled |
Kuraray Co., Ltd. 2003-08-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.