Arcad SmileStudio And Aligner System

Aligner, Sequential

ArcadLab

The following data is part of a premarket notification filed by Arcadlab with the FDA for Arcad Smilestudio And Aligner System.

Pre-market Notification Details

Device IDK192244
510k NumberK192244
Device Name:Arcad SmileStudio And Aligner System
ClassificationAligner, Sequential
Applicant ArcadLab 1860 Old Okeechobee Road, Suite 402 West Palm Beach,  FL  33409
ContactEmerson Cano
CorrespondentPatsy J. Trisler
Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis,  IN  46250
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2020-05-11

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