The following data is part of a premarket notification filed by Kuraray Noritake Dental, Inc. with the FDA for Panavia Sa Cement Plus Handmix.
| Device ID | K142623 |
| 510k Number | K142623 |
| Device Name: | PANAVIA SA Cement Plus Handmix |
| Classification | Cement, Dental |
| Applicant | KURARAY NORITAKE DENTAL, INC. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda Ku, JP 1000004 |
| Contact | Michio Takigawa |
| Correspondent | Michio Takigawa KURARAY NORITAKE DENTAL, INC. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda Ku, JP 1000004 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-16 |
| Decision Date | 2015-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR003359KA1 | K142623 | 000 |
| EKUR003357KA1 | K142623 | 000 |
| EKUR003356KA1 | K142623 | 000 |
| EKUR003355KA1 | K142623 | 000 |
| EKUR003354KA1 | K142623 | 000 |
| EKUR003353KA1 | K142623 | 000 |
| EKUR003352KA1 | K142623 | 000 |