Device Classification Name |
Powder, Porcelain
|
510(k) Number |
K121980 |
Device Name |
ZIRPRIME |
Applicant |
KURARAY NORITAKE DENTAL INC. |
700 12TH ST SW |
SUITE 100 |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
IVAN WASSERMAN |
Correspondent |
KURARAY NORITAKE DENTAL INC. |
700 12TH ST SW |
SUITE 100 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
IVAN WASSERMAN |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 07/06/2012 |
Decision Date | 10/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|