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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Abutment Design Software For Dental Laboratory
510(k) Number K221107
Device Name TRUST
Applicant
Rgorithm Korea
A-1502, 606 Seobusaet-Gil, Guemcheon-Gu, Seoul, 08504,
Republic Of Korea
Geumcheon-Gu,  KR 08504
Applicant Contact Jun Ho Song
Correspondent
Wise Company, Inc.
#507, #508, 166 Gasan Digital 2-Ro
Geumcheon-Gu,  KR 08503
Correspondent Contact Sanglok Lee
Regulation Number872.3630
Classification Product Code
PNP  
Date Received04/15/2022
Decision Date 07/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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