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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 K232740
Device Name Paltop Short Implants
Applicant
Paltop Advanced Dental Solutions, Ltd.
Hashita 5, Industrial Park
Caesarea,  IL 3088900
Applicant Contact Nancy DeAngelo
Correspondent
Paltop Advanced Dental Solutions, Ltd.
Hashita 5, Industrial Park
P.O.Box 3568
Caesarea,  IL 3088900
Correspondent Contact Zina Gurgov
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/07/2023
Decision Date 05/22/2024
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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