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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K231235
Device Name LW UCLA Abutment
Applicant
Ossvis Co., Ltd.
7f And B1, 38, Burim-Ro 170beon-Gil, Dongan-Gu
Anyang-Si,  KR 14055
Applicant Contact Young Jae Kim
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/28/2023
Decision Date 09/15/2023
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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