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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 K181604
Device Name Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
Applicant
HRS Co., Ltd.
7, Chupalsandan 2-gil, Paengseong-eup, Pyeongtaek-si
Gyeonggi-do,  KR 17998
Applicant Contact Seunghwan Go
Correspondent
Onbix Corporation
#821 Samil Plaza, 14 Dogok-ro 1-gil, Gangnam-gu
Seul,  KR 06253
Correspondent Contact Yang Ho Dong
Regulation Number872.3660
Classification Product Code
ELW  
Date Received06/19/2018
Decision Date 11/28/2018
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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