Device Classification Name |
mouthguard, over-the-counter
|
510(k) Number |
K180933 |
Device Name |
DenTek Ultimate Dental Guard |
Applicant |
Medtech Products Inc. |
660 White Plains Rd |
Suite 250 |
Tarrytown,
NY
10591
|
|
Applicant Contact |
Mary Beth Fritz |
Correspondent |
Prestige Brands Holdings |
660 White Plains Road |
Tarrytown,
NY
10591
|
|
Correspondent Contact |
Vincent Argiro |
Classification Product Code |
|
Date Received | 04/10/2018 |
Decision Date | 09/17/2018 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|