U-Aligner

Aligner, Sequential

Universal Orthodontic Laboratory Inc

The following data is part of a premarket notification filed by Universal Orthodontic Laboratory Inc with the FDA for U-aligner.

Pre-market Notification Details

Device IDK191308
510k NumberK191308
Device Name:U-Aligner
ClassificationAligner, Sequential
Applicant Universal Orthodontic Laboratory Inc 11917 Front St. Norwalk,  CA  90650
ContactJiahe Li
CorrespondentJiahe Li
Universal Orthodontic Laboratory Inc 11917 Front St. Norwalk,  CA  90650
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-14
Decision Date2020-04-23

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