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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 K170732
Device Name Biomate Dental Implant System
Applicant
Biomate Medical Devices Technology Co., Ltd.
1f., #59, Luke 2nd Rd.
Luzhu Dist
Kaohsiung City,  TW 820
Applicant Contact Leslie Su
Correspondent
Biomate Medical Devices Technology Co., Ltd.
1f., #59, Luke 2nd Rd.
Luzhu Dist
Kaohsiung City,  TW 820
Correspondent Contact Leslie Su
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/10/2017
Decision Date 10/26/2018
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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