The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Photo Core Plt.
| Device ID | K033970 |
| 510k Number | K033970 |
| Device Name: | CLEARFIL PHOTO CORE PLT |
| 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 | 2003-12-22 |
| Decision Date | 2004-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR000366KA1 | K033970 | 000 |