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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 K210011
Device Name JS Dental Lab Mouth Guard
Applicant
Ampower Dental Laboratories, LLC
3423 Investment Blvd. Suite 11 Hayward
Hayward,  CA  94545
Applicant Contact Dylan Hao
Correspondent
Elexes Medical Consulting, LLC
30 N Gould St., Suite R
Sheridan,  WY  82801
Correspondent Contact Parul Chansoria
Classification Product Code
MQC  
Date Received01/04/2021
Decision Date 07/16/2021
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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