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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 K212496
Device Name Ortho Aligner System
Ortho Lab Services, LLC
251 Little Falls
Wilmington,  DE  19808
Applicant Contact Zuzana Huelsbusch
Qserve Group US, Inc.
7949 Beaumont Green East Drive
Indianapolis,  IN  46250
Correspondent Contact Patsy J. Trisler
Regulation Number872.5470
Classification Product Code
Date Received08/09/2021
Decision Date 11/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No