Ohlendorf Clear Aligner

Aligner, Sequential

Ohlendorf Appliance Laboratory

The following data is part of a premarket notification filed by Ohlendorf Appliance Laboratory with the FDA for Ohlendorf Clear Aligner.

Pre-market Notification Details

Device IDK210540
510k NumberK210540
Device Name:Ohlendorf Clear Aligner
ClassificationAligner, Sequential
Applicant Ohlendorf Appliance Laboratory 2840 Clark Avenue St. Louis,  MO  63103
ContactKevin Ohlendorf
CorrespondentPatsy J. Trisler
Trisler Consulting 7949 Beaumont Green East Drive Indianapolis,  IN  46250
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-24
Decision Date2021-05-19

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