The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Dc Bond.
| Device ID | K062382 |
| 510k Number | K062382 |
| Device Name: | CLEARFIL DC BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York, NY 10022 |
| Contact | Koji Nishida |
| Correspondent | Koji Nishida KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR 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 | 2006-08-15 |
| Decision Date | 2006-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR002513KA1 | K062382 | 000 |
| EKUR002512KA1 | K062382 | 000 |
| EKUR002511KA1 | K062382 | 000 |
| EKUR002510KA1 | K062382 | 000 |