Device Classification Name |
bracket, ceramic, orthodontic
|
510(k) Number |
K123092 |
Device Name |
CERAMIN BRACKETS Z |
Applicant |
TOMY, INC. |
7046 OWL'S NEST TERRACE |
BRADENTON,
FL
34203
|
|
Applicant Contact |
CAROLYN PRIMUS |
Correspondent |
TOMY, INC. |
7046 OWL'S NEST TERRACE |
BRADENTON,
FL
34203
|
|
Correspondent Contact |
CAROLYN PRIMUS |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 10/02/2012 |
Decision Date | 12/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|