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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Orthodontic
510(k) Number K181142
Device Name Absoanchor Microimplant
Applicant
Dentos, Inc.
41, Seongseo-Ro 68-Gil, Dalseo-Gu
Daegu,  KR 42697
Applicant Contact Kim Jin-Hyun
Correspondent
Onbix Corporation
821 Samil Plz., 14, Dogok-Ro 1-Gil
Seoul,  KR 06253
Correspondent Contact Yang Ho Dong
Regulation Number872.3640
Classification Product Code
OAT  
Date Received05/01/2018
Decision Date 02/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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