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FDA 510(k)

Paltop Dental Implant System

K-Number: K243983 · 2025-09-29

ApplicantPaltop Advanced Dental Solutions, Ltd.
Decision Date2025-09-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Paltop Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. It received FDA 510(k) clearance on 2025-09-29 under 510(k) number K243983. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Paltop Dental Implant System?

Paltop Dental Implant System is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. The 510(k) number is K243983.

When did Paltop Dental Implant System receive FDA 510(k) clearance?

Paltop Dental Implant System received FDA 510(k) clearance on 2025-09-29, under 510(k) number K243983.

Who is the listed applicant for Paltop Dental Implant System?

The FDA 510(k) record lists Paltop Advanced Dental Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Paltop Dental Implant System?

The FDA product code for Paltop Dental Implant System is DZE.

Other records listing Paltop Advanced Dental Solutions, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232740Paltop Short ImplantsK220200Paltop Conical Implant SystemK210117Paltop Narrow Implant

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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