Paltop Conical Implant System

Implant, Endosseous, Root-form

Paltop Advanced Dental Solutions, Ltd

The following data is part of a premarket notification filed by Paltop Advanced Dental Solutions, Ltd with the FDA for Paltop Conical Implant System.

Pre-market Notification Details

Device IDK220200
510k NumberK220200
Device Name:Paltop Conical Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Paltop Advanced Dental Solutions, Ltd Hashita 5, Industrial Park Caesarea,  IL 3088900
ContactZina Gurgov
CorrespondentChris Brown
Aclivi, LLC 3250 Brackley Drive Ann Arbor,  MI  48105
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-24
Decision Date2022-05-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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07290114690096 K220200 000

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