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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 K232268
Device Name STERI-OSS Implant System
Applicant
Zeros Co., Ltd.
138-13, Pyeonggang-Ro 345beon-Gil
Gangseo-Gu,  KR 46700
Applicant Contact Uk Hyon Joo
Correspondent
Zeros Co., Ltd.
138-13, Pyeonggang-Ro 345beon-Gil
Gangseo-Gu,  KR 46700
Correspondent Contact Uk Hyon Joo
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/31/2023
Decision Date 03/25/2024
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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