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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, Root-Form
510(k) Number K210039
Device Name CORE1 Implant System
Applicant
Cybermed, Inc.
6-26, Yuseong-Daero 1205 Beon-Gil
Yuseong-Gu,  KR 34104
Applicant Contact Han Seul Kim
Correspondent
Cybermed, Inc.
6-26, Yuseong-Daero 1205 Beon-Gil
Yuseong-Gu,  KR 34104
Correspondent Contact Cheol Young Kim
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/06/2021
Decision Date 01/07/2022
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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