CLEARFIL SILANE KIT
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 Silane Kit.
Pre-market Notification Details
| Device ID | K024356 |
| 510k Number | K024356 |
| Device Name: | CLEARFIL SILANE KIT |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. New York, NY 10022 |
| Contact | Masaya Sasaki |
| Correspondent | Masaya Sasaki 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 | 2002-12-30 |
| Decision Date | 2003-03-26 |
| Summary: | summary |
Trademark Results [CLEARFIL SILANE KIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARFIL SILANE KIT 78138596 2898057 Dead/Cancelled |
Kuraray Co., Ltd. 2002-06-25 |
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