6MS Invisible Aligner

Aligner, Sequential

SMS OPCO, LLC

The following data is part of a premarket notification filed by Sms Opco, Llc with the FDA for 6ms Invisible Aligner.

Pre-market Notification Details

Device IDK210652
510k NumberK210652
Device Name:6MS Invisible Aligner
ClassificationAligner, Sequential
Applicant SMS OPCO, LLC 672 Morning Star Drive, Suite 120 The Colony,  TX  75056
ContactBruce Page
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 Received2021-03-04
Decision Date2021-06-02

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