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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 K172821
Device Name Ti-one 101 TS Dental Implant System
Applicant
Hung Chun Bio-S Co., Ltd.
# 12, Luke 1st Rd., Luzhu Dist.
Kaohsiung,  TW 821
Applicant Contact Jethro Liou
Correspondent
Hung Chun Bio-S Co., Ltd.
# 12, Luke 1st Rd., Luzhu Dist.
Kaohsiung,  TW 821
Correspondent Contact Allison Liu
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/18/2017
Decision Date 06/11/2018
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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