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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K251491
Device Name K5 Cart, K5 Mount, K5 Swing
Applicant
Osstem Implant Company., Ltd. Chair Business
192, Haebong-Ro, Danwon-Gu
Ansan-Si,  KR 15428
Applicant Contact Jimin Hyun
Correspondent
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact Leszczak Mateusz
Regulation Number872.6640
Classification Product Code
EIA  
Subsequent Product Code
KLC  
Date Received05/14/2025
Decision Date 07/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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