CUSTMBITE Snoring System

Device, Anti-snoring

Dental Choice Holdings LLC

The following data is part of a premarket notification filed by Dental Choice Holdings Llc with the FDA for Custmbite Snoring System.

Pre-market Notification Details

Device IDK221322
510k NumberK221322
Device Name:CUSTMBITE Snoring System
ClassificationDevice, Anti-snoring
Applicant Dental Choice Holdings LLC 10100 Linn Station Road Louisville,  KY  40223
ContactDanielle M Jackson
CorrespondentYolanda Smith
Smith Associates 1468 Harwell Ave. Crofton,  MD  21114
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-06
Decision Date2022-10-27

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