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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K240597
Device Name TERA HARZ CLEAR
Applicant
Graphy, Inc.
#603,#617, Acegasanforhu 225, Gasan Digital 1-Ro
Geumcheon-Gu
Seoul,  KR 08501
Applicant Contact Moon-Soo Park
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.5470
Classification Product Code
NXC  
Date Received03/04/2024
Decision Date 03/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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