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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 K192338
Device Name NEOLab Clear Aligners
Applicant
New England Ortho Lab, Inc.
3 Riverside Drive
Andover,  MA  01810
Applicant Contact Olivia Channon
Correspondent
Qserve Group US, Inc.
7949 Beaumont Green East Drive
Indianapolis,  IN  46250
Correspondent Contact Patsy J Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received08/28/2019
Decision Date 03/12/2020
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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