Device Classification Name |
Mouthguard, Over-The-Counter
|
510(k) Number |
K121272 |
Device Name |
PROTECH DENT |
Applicant |
AKERVALL TECHNOLOGIES INC |
5520 STONE VALLEY DRIVE |
ANN ARBOR,
MI
48105
|
|
Applicant Contact |
SASSA AKERVALL |
Correspondent |
AKERVALL TECHNOLOGIES INC |
5520 STONE VALLEY DRIVE |
ANN ARBOR,
MI
48105
|
|
Correspondent Contact |
SASSA AKERVALL |
Classification Product Code |
|
Date Received | 04/27/2012 |
Decision Date | 10/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|