The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Clearfil Majety Posterior.
| Device ID | K100328 |
| 510k Number | K100328 |
| Device Name: | CLEARFIL MAJETY POSTERIOR |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York, NY 10022 |
| Contact | Kiyoyuki Arikawa |
| Correspondent | Kiyoyuki Arikawa KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR New York, NY 10022 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-04 |
| Decision Date | 2010-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR002594KA1 | K100328 | 000 |
| EKUR002593KA1 | K100328 | 000 |
| EKUR002586KA1 | K100328 | 000 |
| EKUR002582KA1 | K100328 | 000 |
| EKUR002581KA1 | K100328 | 000 |
| EKUR002580KA1 | K100328 | 000 |