| Device Classification Name |
bracket, ceramic, orthodontic |
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|---|---|---|---|---|
| 510(k) Number | K111234 | |||
| Device Name | CLICK-IT | |||
| Applicant |
|
|||
| Applicant Contact | robin intagliata | |||
| Regulation Number | 872.5470 | |||
| Classification Product Code |
|
|||
| Date Received | 05/02/2011 | |||
| Decision Date | 05/13/2011 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Dental |
|||
| 510k Review Panel |
Dental |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | Yes | |||
| Combination Product |
No |