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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, Ace Gasan Forhu, 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
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