MyClearALIGN Dental Aligner System

Aligner, Sequential

Key Dental Technologies, LLC

The following data is part of a premarket notification filed by Key Dental Technologies, Llc with the FDA for Myclearalign Dental Aligner System.

Pre-market Notification Details

Device IDK221475
510k NumberK221475
Device Name:MyClearALIGN Dental Aligner System
ClassificationAligner, Sequential
Applicant Key Dental Technologies, LLC 920 MLK Blvd Suite 920-B Chapel Hill,  NC  27517
ContactLarry Moray
CorrespondentThomas Padula
Schiff & Company, Inc. 583 Mountain Avenue North Caldwell,  NJ  07006
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-20
Decision Date2022-08-31

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