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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K222741
Device Name DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
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 Number872.3660
Classification Product Code
ELW  
Date Received09/09/2022
Decision Date 11/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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