The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Cleafil Dc Core Automix.
| Device ID | K043177 |
| 510k Number | K043177 |
| Device Name: | CLEAFIL DC CORE AUTOMIX |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. New York, NY 10022 |
| Contact | Satoshi Yamaguchi |
| Correspondent | Satoshi Yamaguchi KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. New York, NY 10022 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-16 |
| Decision Date | 2004-12-17 |