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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K202465
Device Name Night Guard
Applicant
3D Diagnostix Inc.
24 Denby Road
Allston,  MA  02134
Applicant Contact Ehab Amin
Correspondent
3D Diagnostix Inc.
24 Denby Road
Allston,  MA  02134
Correspondent Contact Ehab Amin
Classification Product Code
MQC  
Date Received08/27/2020
Decision Date 11/25/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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