Device Classification Name |
Varnish, Cavity
|
510(k) Number |
K120176 |
Device Name |
SENZZZZZ AWAY |
Applicant |
CENTRIX, INC. |
11234 EL CAMINO REAL |
STE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
LINDA K SCHULZ |
Correspondent |
CENTRIX, INC. |
11234 EL CAMINO REAL |
STE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
LINDA K SCHULZ |
Regulation Number | 872.3260
|
Classification Product Code |
|
Date Received | 01/20/2012 |
Decision Date | 07/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|