Device Classification Name |
bracket, ceramic, orthodontic
|
510(k) Number |
K113334 |
Device Name |
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS |
Applicant |
OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC. |
10200 SOUTH 505 WEST |
SOUTH JORDAN,
UT
84095
|
|
Applicant Contact |
DIANE ROGERS |
Correspondent |
OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC. |
10200 SOUTH 505 WEST |
SOUTH JORDAN,
UT
84095
|
|
Correspondent Contact |
DIANE ROGERS |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 11/14/2011 |
Decision Date | 02/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|