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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthodontic software
510(k) Number K193003
Device Name NemoCast
Software Nemotec S.L.
Juan de la Cierva Street, 66
Arroyomolinos, Madrid,  ES 28939
Applicant Contact Carlos Arias
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number872.5470
Classification Product Code
Subsequent Product Code
Date Received10/28/2019
Decision Date 06/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No