FDA.report

510(k) K202974

Device
DenTek Fresh Protect Dental Guard
Applicant
Medtech Products, Inc.
510(k) number
K202974
Product code
OBR
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-22
Date received
2020-09-30
Classification name
Mouthguard, Over-The-Counter
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Vincent Argiro
Address
660 White Plains Rd. Tarrytown NY US 10591 10591

FDA Registration Numbers

Source Documents

510(k) summary PDF

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