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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 K173623
Device Name Anchor plate
Applicant
Biomaterials Korea, Inc.
#413, #329, #331 150, Jojeong-Daero
Hanam-Si,  KR 12930
Applicant Contact Jiyea Kim
Correspondent
Regulatory Insight, Inc.
#413 #329 #331, 150 Jojeong-Daero, Hanam-Si
Gyeonggi-Do,  KR 12930
Correspondent Contact Jiyea Kim
Regulation Number872.3640
Classification Product Code
OAT  
Date Received11/24/2017
Decision Date 08/30/2018
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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