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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 K223355
Device Name Tera Harz Clear
Applicant
Graphy, Inc.
603, #617, Ace Gasan Forhu, 225, Gasan Digital 1-Ro,
Geumcheon-Gu,
Seoul,  KR 08503
Applicant Contact Moon Soo Part
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.5470
Classification Product Code
NXC  
Date Received11/02/2022
Decision Date 11/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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