Ortho Aligner System

Aligner, Sequential

Ortho Lab Services, LLC

The following data is part of a premarket notification filed by Ortho Lab Services, Llc with the FDA for Ortho Aligner System.

Pre-market Notification Details

Device IDK212496
510k NumberK212496
Device Name:Ortho Aligner System
ClassificationAligner, Sequential
Applicant Ortho Lab Services, LLC 251 Little Falls Wilmington,  DE  19808
ContactZuzana Huelsbusch
CorrespondentPatsy J. Trisler
Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis,  IN  46250
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-09
Decision Date2021-11-04

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