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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 K161335
Device Name Dual Top Screw System
Applicant
Jeil Medical Corporation
702, 703, 704, 705, 706, 804, 805,807,812-Ho ,55,
Digital-Ro34-Gil, Guro-Gu
Seoul,  KR 08378
Applicant Contact SEUNGYOUNG LEE
Correspondent
Jeil Medical Corporation
702, 703, 704, 705, 706, 804, 805,807,812-Ho ,55,
Digital-Ro34-Gil, Guro-Gu
Seoul,  KR 08378
Correspondent Contact SEUNGYOUNG LEE
Regulation Number872.3640
Classification Product Code
OAT  
Date Received05/12/2016
Decision Date 02/23/2017
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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