Device Classification Name |
powder, porcelain
|
510(k) Number |
K193060 |
Device Name |
Noritake Super Porcelain EX-3 |
Applicant |
Kuraray Noritake Dental Inc. |
Ote Center Bldg. 7F |
Chiyoda-ku,
JP
100-0004
|
|
Applicant Contact |
Yasujiro Ohara |
Correspondent |
Kuraray Noritake Dental Inc. |
Ote Center Bldg. 7F |
Chiyoda-ku,
JP
100-0004
|
|
Correspondent Contact |
Yasujiro Ohara |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 11/01/2019 |
Decision Date | 01/30/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|