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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 K222245
Device Name ACR Screw System
Applicant
BioMaterials Korea, Inc
#329, #331, #413 150, Jojeong-daero
Hanam-si,  KR 12930
Applicant Contact Young-yeop Kim
Correspondent
SMB Korea
#606, #607, 7, Borame-ro 5ga-gil
Donjak-gu
Seoul,  KR 07071
Correspondent Contact Kyung-hwan Kim
Regulation Number872.3640
Classification Product Code
OAT  
Date Received07/26/2022
Decision Date 08/21/2023
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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