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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 K241616
Device Name ALLONUS Tech Prosthetics
Applicant
Allonus Tech Co., Ltd.
23-3, Sanmakgongdannam 4-Gil
Yangsan-Si,  KR 50568
Applicant Contact Daniel Kwon
Correspondent
Allonus Tech Co., Ltd.
23-3, Sanmakgongdannam 4-Gil
Yangsan-Si,  KR 50568
Correspondent Contact Daniel Kwon
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/05/2024
Decision Date 12/17/2024
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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