| Device Classification Name |
Bracket, Plastic, Orthodontic
|
| 510(k) Number |
K874227 |
| Device Name |
PLASTIC BRACKETS |
| Applicant |
| Advanced Orthodontics Systems, Inc. |
| 2346 Flatbush Ave. |
|
Brooklyn,
NY
11234
|
|
| Applicant Contact |
LAWRENCE HERMANN,DDS |
| Correspondent |
| Advanced Orthodontics Systems, Inc. |
| 2346 Flatbush Ave. |
|
Brooklyn,
NY
11234
|
|
| Correspondent Contact |
LAWRENCE HERMANN,DDS |
| Regulation Number | 872.5470 |
| Classification Product Code |
|
| Date Received | 10/16/1987 |
| Decision Date | 12/29/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|