The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Panavia Veneer Lc.
| Device ID | K210504 |
| 510k Number | K210504 |
| Device Name: | PANAVIA Veneer LC |
| 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 | 2021-02-22 |
| Decision Date | 2021-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR004513KA0 | K210504 | 000 |
| EKUR004510KA1 | K210504 | 000 |
| EKUR004508KA1 | K210504 | 000 |
| EKUR004507KA1 | K210504 | 000 |
| EKUR004506KA1 | K210504 | 000 |
| EKUR004505KA1 | K210504 | 000 |
| EKUR004502KA1 | K210504 | 000 |
| EKUR004511KA1 | K210504 | 000 |
| EKUR004504KA1 | K210504 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PANAVIA VENEER LC 90148747 not registered Live/Pending |
KURARAY CO., LTD. 2020-08-31 |
![]() PANAVIA VENEER LC 90148738 not registered Live/Pending |
KURARAY CO., LTD. 2020-08-31 |