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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K222414
Device Name TERA HARZ DENTURE
Applicant
Graphy, Inc.
603, #617, Ace Gasan Forhu, 225, Gasan Digital 1-Ro,
Geumcheon-Gu,
Seoul,  KR 08503
Applicant Contact Tae-woo Kim
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.3760
Classification Product Code
EBI  
Date Received08/10/2022
Decision Date 08/11/2022
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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