NEOLab Clear Aligners

Aligner, Sequential

New England Ortho Lab, Inc.

The following data is part of a premarket notification filed by New England Ortho Lab, Inc. with the FDA for Neolab Clear Aligners.

Pre-market Notification Details

Device IDK192338
510k NumberK192338
Device Name:NEOLab Clear Aligners
ClassificationAligner, Sequential
Applicant New England Ortho Lab, Inc. 3 Riverside Drive Andover,  MA  01810
ContactOlivia Channon
CorrespondentPatsy J Trisler
Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis,  IN  46250
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-28
Decision Date2020-03-12

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