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 |