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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 K212702
Device Name IM/ST Fixture System
Applicant
Guilin Fiteeth Medical Instrument Co., Ltd.
Southeast Side Of Renmin Rd. Extension Line,
Yangtang Industrial Park, Lingui District
Guilin,  CN 541199
Applicant Contact Jun Zhou
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/26/2021
Decision Date 10/13/2022
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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