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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 K192244
Device Name Arcad SmileStudio and Aligner System
Applicant
Arcadlab
1860 Old Okeechobee Rd., Suite 402
West Palm Beach,  FL  33409
Applicant Contact Emerson Cano
Correspondent
Qserve Group, Us, Inc.
7949 Beaumont Green E. Dr.
Indianapolis,  IN  46250
Correspondent Contact Patsy J. Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Subsequent Product Code
PNN  
Date Received08/19/2019
Decision Date 05/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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