The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Se Bond Plus.
| Device ID | K023842 |
| 510k Number | K023842 |
| Device Name: | CLEARFIL SE BOND PLUS |
| 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 | 2002-11-18 |
| Decision Date | 2003-02-11 |
| Summary: | summary |