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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K210540
Device Name Ohlendorf Clear Aligner
Applicant
Ohlendorf Appliance Laboratory
2840 Clark Avenue
St. Louis,  MO  63103
Applicant Contact Kevin Ohlendorf
Correspondent
Trisler Consulting
7949 Beaumont Green East Drive
Indianapolis,  IN  46250
Correspondent Contact Patsy J. Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received02/24/2021
Decision Date 05/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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