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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 Plaza, 14, Dogok-ro 1-gil, Gangnam-gu
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
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