Device Classification Name |
mouthguard, over-the-counter
|
510(k) Number |
K091660 |
Device Name |
CUSTOM COMFORT NIGHTGUARD VERSION 2 |
Applicant |
DENTEK ORAL CARE, INC. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
HOWARD M HOLSTEIN |
Correspondent |
DENTEK ORAL CARE, INC. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
HOWARD M HOLSTEIN |
Classification Product Code |
|
Date Received | 06/09/2009 |
Decision Date | 06/12/2009 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|