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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
Predetermined Change
Control Plan Authorized		 No
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