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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 K161197
Device Name Orthodontic Screw
Applicant
OSSTEM IMPLANT CO., LTD.
66-16, BANSONG-RO 513BEON-GIL, HAEUNDAE-GU
BUSAN,  KR 612-070
Applicant Contact NA HEEKWON
Correspondent
HIOSSEN INC.
85 BEN FAIRLESS DR.
FAIRLESS HILLS,  PA  19030
Correspondent Contact DAVID KIM
Regulation Number872.3640
Classification Product Code
OAT  
Date Received04/28/2016
Decision Date 12/21/2016
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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