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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
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