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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 K180565
Device Name PEAK NS033CF, PEAK NS017CF
Applicant
Neosil Co., Ltd.
63, Gongdanseo-Ro 18beon-Gil, Geumjeong-Gu
Gyeongsangnam-Do,  KR 46332
Applicant Contact Woo-ryong Ryou
Correspondent
Onbix Corporation
#821 Samil Plz., 14, Dogok-Ro 1-Gil, Gangnam-Gu
Seoul,  KR 06523
Correspondent Contact Yang Ho Dong
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/05/2018
Decision Date 06/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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