The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Clearfil Majesty Flow.
| Device ID | K121583 |
| 510k Number | K121583 |
| Device Name: | CLEARFIL MAJESTY FLOW |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY NORITAKE DENTAL INC. 33 MAIDEN LANE, 6TH FLOOR New York, NY 10038 |
| Contact | Kiyoyuki Arikawa |
| Correspondent | Kiyoyuki Arikawa KURARAY NORITAKE DENTAL INC. 33 MAIDEN LANE, 6TH FLOOR New York, NY 10038 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-30 |
| Decision Date | 2012-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR003066KA1 | K121583 | 000 |
| EKUR003055KA1 | K121583 | 000 |
| EKUR003054KA1 | K121583 | 000 |
| EKUR003053KA1 | K121583 | 000 |
| EKUR003052KA1 | K121583 | 000 |
| EKUR003051KA1 | K121583 | 000 |
| EKUR003050KA1 | K121583 | 000 |
| EKUR003037KA1 | K121583 | 000 |
| EKUR003036KA1 | K121583 | 000 |
| EKUR003056KA1 | K121583 | 000 |
| EKUR003057KA1 | K121583 | 000 |
| EKUR003065KA1 | K121583 | 000 |
| EKUR003064KA1 | K121583 | 000 |
| EKUR003063KA1 | K121583 | 000 |
| EKUR003062KA1 | K121583 | 000 |
| EKUR003061KA1 | K121583 | 000 |
| EKUR003060KA1 | K121583 | 000 |
| EKUR003059KA1 | K121583 | 000 |
| EKUR003058KA1 | K121583 | 000 |
| EKUR003035KA1 | K121583 | 000 |
| EKUR003034KA1 | K121583 | 000 |
| EKUR003033KA1 | K121583 | 000 |
| EKUR003022KA1 | K121583 | 000 |
| EKUR003021KA1 | K121583 | 000 |
| EKUR003020KA1 | K121583 | 000 |
| EKUR003016KA1 | K121583 | 000 |
| EKUR003015KA1 | K121583 | 000 |
| EKUR003011KA1 | K121583 | 000 |
| EKUR003191KA0 | K121583 | 000 |
| EKUR003188KA1 | K121583 | 000 |
| EKUR003023KA1 | K121583 | 000 |
| EKUR003024KA1 | K121583 | 000 |
| EKUR003032KA1 | K121583 | 000 |
| EKUR003031KA1 | K121583 | 000 |
| EKUR003030KA1 | K121583 | 000 |
| EKUR003029KA1 | K121583 | 000 |
| EKUR003028KA1 | K121583 | 000 |
| EKUR003027KA1 | K121583 | 000 |
| EKUR003026KA1 | K121583 | 000 |
| EKUR003025KA1 | K121583 | 000 |
| EKUR003181KA1 | K121583 | 000 |
| EKUR003157KA1 | K121583 | 000 |
| EKUR003146KA1 | K121583 | 000 |
| EKUR003145KA1 | K121583 | 000 |
| EKUR003144KA1 | K121583 | 000 |
| EKUR003143KA1 | K121583 | 000 |
| EKUR003142KA1 | K121583 | 000 |
| EKUR003141KA1 | K121583 | 000 |
| EKUR003140KA1 | K121583 | 000 |
| EKUR003127KA1 | K121583 | 000 |
| EKUR003147KA1 | K121583 | 000 |
| EKUR003148KA1 | K121583 | 000 |
| EKUR003156KA1 | K121583 | 000 |
| EKUR003155KA1 | K121583 | 000 |
| EKUR003154KA1 | K121583 | 000 |
| EKUR003153KA1 | K121583 | 000 |
| EKUR003152KA1 | K121583 | 000 |
| EKUR003151KA1 | K121583 | 000 |
| EKUR003150KA1 | K121583 | 000 |
| EKUR003149KA1 | K121583 | 000 |
| EKUR003126KA1 | K121583 | 000 |
| EKUR003125KA1 | K121583 | 000 |
| EKUR003124KA1 | K121583 | 000 |
| EKUR003113KA1 | K121583 | 000 |
| EKUR003112KA1 | K121583 | 000 |
| EKUR003111KA1 | K121583 | 000 |
| EKUR003110KA1 | K121583 | 000 |
| EKUR003106KA1 | K121583 | 000 |
| EKUR003105KA1 | K121583 | 000 |
| EKUR003101KA1 | K121583 | 000 |
| EKUR003100KA1 | K121583 | 000 |
| EKUR003114KA1 | K121583 | 000 |
| EKUR003115KA1 | K121583 | 000 |
| EKUR003123KA1 | K121583 | 000 |
| EKUR003122KA1 | K121583 | 000 |
| EKUR003121KA1 | K121583 | 000 |
| EKUR003120KA1 | K121583 | 000 |
| EKUR003119KA1 | K121583 | 000 |
| EKUR003118KA1 | K121583 | 000 |
| EKUR003117KA1 | K121583 | 000 |
| EKUR003116KA1 | K121583 | 000 |
| EKUR003067KA1 | K121583 | 000 |