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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 K243983
Device Name Paltop Dental Implant System
Applicant
Paltop Advanced Dental Solutions, Ltd.
Hashita 5, Industrial Park
Caesarea,  IL 3088900
Applicant Contact Zina Gurgov
Correspondent
Paltop Advanced Dental Solutions, Ltd.
13645 Alton Pkwy.
Irvine,  CA  92618
Correspondent Contact Adam Johnson
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/23/2024
Decision Date 09/29/2025
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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