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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 K231753
Device Name Oneday Implant Abutment
Applicant
Oneday Biotech Co., Ltd.
135 Seongseodongro, Dalseogu
Daegu,  KR 42721
Applicant Contact Jinhwan Kim
Correspondent
Withus Group Inc
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/15/2023
Decision Date 02/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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