CLEARFIL NEW 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 New Bond.
Pre-market Notification Details
| Device ID | K012734 |
| 510k Number | K012734 |
| Device Name: | CLEARFIL NEW BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY MEDICAL INC. 30TH FL. METLIFE BUILDING 200 PARK AVENUE New York, NY 10166 |
| Contact | Masaya Sasaki |
| Correspondent | Masaya Sasaki KURARAY MEDICAL INC. 30TH FL. METLIFE BUILDING 200 PARK AVENUE New York, NY 10166 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-14 |
| Decision Date | 2001-09-14 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR000054KA1 | K012734 | 000 |
| EKUR000053KA1 | K012734 | 000 |
Trademark Results [CLEARFIL NEW BOND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARFIL NEW BOND 73546635 1428071 Live/Registered |
KURARAY CO., LTD. 1985-07-05 |
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