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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 K232549
Device Name NemoCast
Applicant
Software Nemotec S.L.
Av. Juan Caramuel, 1
Leganes,  ES 28919
Applicant Contact Miguel del Moral
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received08/23/2023
Decision Date 11/21/2023
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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