The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Ap-x Plt.
| Device ID | K023002 |
| 510k Number | K023002 |
| Device Name: | CLEARFIL AP-X PLT |
| Classification | Material, Tooth Shade, 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2002-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR001755KA1 | K023002 | 000 |
| EKUR001754KA1 | K023002 | 000 |
| EKUR001751KA1 | K023002 | 000 |
| EKUR001746KA1 | K023002 | 000 |
| EKUR001745KA1 | K023002 | 000 |
| EKUR001744KA1 | K023002 | 000 |
| EKUR001743KA1 | K023002 | 000 |
| EKUR001742KA1 | K023002 | 000 |
| EKUR001741KA1 | K023002 | 000 |