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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K213339
Device Name DENU Composite Resin, DENU Flow Resin
Applicant
Hdi, Inc.
A-1504, 14, Sagimakgol-Ro, 45 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13209
Applicant Contact Taekyou Kim
Correspondent
Hdi, Inc.
A-1504, 14, Sagimakgol-Ro, 45 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13209
Correspondent Contact Taekyou Kim
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBC  
Date Received10/07/2021
Decision Date 09/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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