Device Classification Name |
aligner, sequential
|
510(k) Number |
K121396 |
Device Name |
DYNAFLEX |
Applicant |
DYNA FLEX |
10403 International Plaza Dr. |
Northwest Plaza,
MO
63074
|
|
Applicant Contact |
MATTHEW MALABEY |
Correspondent |
DYNA FLEX |
10403 International Plaza Dr. |
Northwest Plaza,
MO
63074
|
|
Correspondent Contact |
MATTHEW MALABEY |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 05/09/2012 |
Decision Date | 08/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|