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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 K183044
Device Name JTK Dental Implant System
Applicant
Jiangyin Jintech Biotech Co., Ltd.
Bldg. D1, #6 Dongshengxi Rd.
Jiangyin City,  CN 214437
Applicant Contact Jie Zhang
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received11/02/2018
Decision Date 11/10/2020
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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