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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 K171197
Device Name Zuga Dental Implant System
Applicant
Zuga Medical, Inc.
24400 Chagrin Blvd., Suite 250
Beachwood,  OH  44122
Applicant Contact Chan Wang
Correspondent
Zuga Medical, Inc.
24400 Chagrin Blvd., Suite 250
Beachwood,  OH  44122
Correspondent Contact Chan Wang
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/24/2017
Decision Date 06/30/2018
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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