The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Panavia Sa Cement Universal.
| Device ID | K183537 |
| 510k Number | K183537 |
| Device Name: | PANAVIA SA Cement Universal |
| Classification | Cement, Dental |
| Applicant | Kuraray Noritake Dental Inc. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku, JP 100-0004 |
| Contact | Yasujiro Ohara |
| Correspondent | Yasujiro Ohara Kuraray Noritake Dental Inc. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku, JP 100-0004 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-19 |
| Decision Date | 2019-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR004221KA1 | K183537 | 000 |
| EKUR004203KA1 | K183537 | 000 |
| EKUR004204KA1 | K183537 | 000 |
| EKUR004210KA1 | K183537 | 000 |
| EKUR004211KA1 | K183537 | 000 |
| EKUR004212KA1 | K183537 | 000 |
| EKUR004213KA1 | K183537 | 000 |
| EKUR004214KA1 | K183537 | 000 |
| EKUR004216KA1 | K183537 | 000 |
| EKUR004217KA1 | K183537 | 000 |
| EKUR004218KA1 | K183537 | 000 |
| EKUR004202KA1 | K183537 | 000 |