The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Noritake Super Porcelain Ex-3.
Device ID | K193060 |
510k Number | K193060 |
Device Name: | Noritake Super Porcelain EX-3 |
Classification | Powder, Porcelain |
Applicant | Kuraray Noritake Dental Inc. Ote Center Bldg. 7F Chiyoda-ku, JP 100-0004 |
Contact | Yasujiro Ohara |
Correspondent | Yasujiro Ohara Kuraray Noritake Dental Inc. Ote Center Bldg. 7F Chiyoda-ku, JP 100-0004 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-01 |
Decision Date | 2020-01-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NORITAKE SUPER PORCELAIN EX-3 74336446 1807301 Live/Registered |
NORITAKE CO., LIMITED 1992-12-03 |