Clearform Aligners

Aligner, Sequential

Motor City Lab Works

The following data is part of a premarket notification filed by Motor City Lab Works with the FDA for Clearform Aligners.

Pre-market Notification Details

Device IDK191838
510k NumberK191838
Device Name:Clearform Aligners
ClassificationAligner, Sequential
Applicant Motor City Lab Works 2200 Holland Street Birmingham,  MI  48009
ContactChristina Groth
CorrespondentChris Brown
Aclivi, LLC 6455 Farley Road Pinckney,  MI  48169
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-09
Decision Date2020-03-20

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