| Device Classification Name |
Bracket, Metal, Orthodontic
|
| 510(k) Number |
K925028 |
| Device Name |
FORESTADENT ORTHODONTIC BANDS |
| Applicant |
| Forestadent |
| 7530 Pforzheim Westliche 151 |
| Postfach 660 |
|
Germany,
DE
|
|
| Applicant Contact |
FORSTER GMB |
| Correspondent |
| Forestadent |
| 7530 Pforzheim Westliche 151 |
| Postfach 660 |
|
Germany,
DE
|
|
| Correspondent Contact |
FORSTER GMB |
| Regulation Number | 872.5410 |
| Classification Product Code |
|
| Date Received | 10/02/1992 |
| Decision Date | 01/26/1994 |
| 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
|
|
|