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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K221022
Device Name NextDent Ortho Flex
Applicant
Vertex-Dental B.V.
Centurionbaan 190
Soesterberg,  NL 3769AV
Applicant Contact Connie Peterse-van der Koppel
Correspondent
Qserve Group, Us, Inc.
7949 Beaumont Green E. Dr.
Indianapolis,  IN  46250
Correspondent Contact Patsy J. Trisler
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received04/06/2022
Decision Date 10/21/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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