The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Clearfil Majesty Es Flow.
| Device ID | K130371 |
| 510k Number | K130371 |
| Device Name: | CLEARFIL MAJESTY ES FLOW |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY NORITAKE DENTAL INC. OTE CENTER BLDG 7F 1-1-3, OTEMACHI Chiyoda-ku, JP 100-0004 |
| Contact | Michio Takigawa |
| Correspondent | Michio Takigawa KURARAY NORITAKE DENTAL INC. OTE CENTER BLDG 7F 1-1-3, OTEMACHI Chiyoda-ku, JP 100-0004 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-14 |
| Decision Date | 2013-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR003331KA1 | K130371 | 000 |
| EKUR003302KA1 | K130371 | 000 |
| EKUR003303KA1 | K130371 | 000 |
| EKUR003304KA1 | K130371 | 000 |
| EKUR003305KA1 | K130371 | 000 |
| EKUR003306KA1 | K130371 | 000 |
| EKUR003307KA1 | K130371 | 000 |
| EKUR003308KA1 | K130371 | 000 |
| EKUR003309KA1 | K130371 | 000 |
| EKUR003312KA1 | K130371 | 000 |
| EKUR003317KA1 | K130371 | 000 |
| EKUR003301KA1 | K130371 | 000 |