Device Classification Name |
adhesive, bracket and tooth conditioner, resin
|
510(k) Number |
K202276 |
Device Name |
BracePaste Band and Build LC |
Applicant |
American Orthodontics |
3524 Washington Avenue |
Sheboygan,
WI
53081
|
|
Applicant Contact |
Andre Leak |
Correspondent |
Accelerated Device Approval Services |
6800 S.W. 40th Street, Ste. 403 |
Ludlum,
FL
33155
|
|
Correspondent Contact |
Rafael Aguila |
Regulation Number | 872.3750
|
Classification Product Code |
|
Date Received | 08/11/2020 |
Decision Date | 08/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|