Device Classification Name |
Bracket, Ceramic, Orthodontic
|
510(k) Number |
K152779 |
Device Name |
Avex CX2 |
Applicant |
Opal Orthodontics by Ultradent Products |
505 West 10200 South |
South Jordan,
UT
84095
|
|
Applicant Contact |
Marie Hess |
Correspondent |
Opal Orthodontics by Ultradent Products |
505 West 10200 South |
South Jordan,
UT
84095
|
|
Correspondent Contact |
Marie Hess |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 09/25/2015 |
Decision Date | 11/25/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|