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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 K212770
Device Name Vision
Applicant
SoftSmile, Inc.
16192 Coastal Highway
Lewes,  DE  19958
Applicant Contact Khamzat Asabaev
Correspondent
Hyman, Phelps & McNamara
700 Thirteenth Street NW, Suite 1200
Washington,  DC  20005
Correspondent Contact Allyson B. Mullen
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received08/31/2021
Decision Date 12/21/2021
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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