JS Dental Lab Mouth Guard

Mouthguard, Prescription

Ampower Dental Laboratories, LLC

The following data is part of a premarket notification filed by Ampower Dental Laboratories, Llc with the FDA for Js Dental Lab Mouth Guard.

Pre-market Notification Details

Device IDK210011
510k NumberK210011
Device Name:JS Dental Lab Mouth Guard
ClassificationMouthguard, Prescription
Applicant Ampower Dental Laboratories, LLC 3423 Investment Blvd Suite 11 Hayward Hayward,  CA  94545
ContactDylan Hao
CorrespondentParul Chansoria
Elexes Medical Consulting, LLC 30 N Gould St Ste R Sheridan,  WY  82801
Product CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-07-16

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