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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 K220200
Device Name Paltop Conical Implant System
Applicant
Paltop Advanced Dental Solutions, Ltd
Hashita 5, Industrial Park
Caesarea,  IL 3088900
Applicant Contact Zina Gurgov
Correspondent
Aclivi, LLC
3250 Brackley Drive
Ann Arbor,  MI  48105
Correspondent Contact Chris Brown
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/24/2022
Decision Date 05/25/2022
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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