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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
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