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 IDK203339
510k NumberK203339
Device Name:NEOLab Clear Aligners
ClassificationAligner, Sequential
Applicant New England Ortho Lab, Inc 3 Riverside Drive Andover,  MA  01810
ContactChristian Saurman
CorrespondentOlivia Channon
New England Ortho Lab, Inc 3 Riverside Drive Andover,  MA  01810
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-12
Decision Date2021-01-06

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