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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 K192701
Device Name DIBS (Digital Indirect Bonding System)
Applicant
OrthoSelect, LLC
831 E 340 S Suite 170
American Fork,  UT  84003
Applicant Contact Steven N. Gardner
Correspondent
E.M.M.A International Consulting Group Inc.
27600 Farmington Road, Suite 100
Farmington Hills,  MI  48334
Correspondent Contact Carmine Jabri
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received09/27/2019
Decision Date 04/21/2020
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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