Vivid Aligners

Aligner, Sequential

Orthodent Laboratory, Inc.

The following data is part of a premarket notification filed by Orthodent Laboratory, Inc. with the FDA for Vivid Aligners.

Pre-market Notification Details

Device IDK190003
501k NumberK190003
Device Name:Vivid Aligners
ClassificationAligner, Sequential
Applicant Orthodent Laboratory, Inc. 6325 Sheridan Drive Buffalo,  NY  14221
ContactMichael Wright
CorrespondentRobert O. Dean
Compliance Systems International, LLC. 1083 Delaware Ave. Buffalo,  NY  14209
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-02
Decision Date2019-11-06

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