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Paltop Short Implants

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232740

by Paltop Advanced Dental Solutions, Ltd.

Identifiers

510(k) Number
K232740 FDA 510(k)
FDA Product Code
DZE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Paltop Short Implants are endosseous screw-type dental implants designed for dental restoration. These devices are intended for use in two-stage surgical procedures to replace missing teeth by integrating with the jawbone, providing a stable foundation for prosthetic crowns or bridges. Their design supports marginal bone preservation and offers compatibility with cement-retained abutments for restorative flexibility.

The implants are supplied as part of a complete system, including compatible abutments and surgical components. They are intended for single-use and are regulated under FDA 510(k) clearance (K232740) as a substantially equivalent dental device. No information regarding sterility, MRI safety, or reusable status is provided in the specifications. Storage and handling instructions are not detailed beyond standard medical device protocols.

Frequently asked questions

What is the Paltop Short Implants system used for?

The Paltop Short Implants are endosseous screw-type dental implants intended for replacing missing teeth through a two-stage surgical procedure. They integrate with the jawbone to create a stable foundation for prosthetic crowns or bridges. The design emphasizes marginal bone preservation, ensuring long-term stability while offering flexibility for cement-retained abutments in restorative dentistry.

Are the Paltop Short Implants supplied as a standalone device or as part of a complete system?

The Paltop Short Implants are supplied as part of a complete system, including compatible abutments and surgical components. This ensures all necessary components for placement and restoration are available, simplifying the clinical workflow and ensuring proper integration for dental restoration.

Are Paltop Short Implants intended for single-use or reuse?

The Paltop Short Implants are designed for single-use only. This aligns with standard medical device practices to maintain sterility and patient safety, reducing the risk of cross-contamination and ensuring consistent performance during dental procedures.

What regulatory clearance does the Paltop Short Implants system hold?

The Paltop Short Implants system holds FDA 510(k) clearance under the reference number K232740. This clearance categorizes the device as substantially equivalent to a predicate dental implant, confirming its compliance with regulatory standards for safety and effectiveness in dental restoration.

Are there specific storage instructions provided for the Paltop Short Implants?

The provided specifications do not include detailed storage instructions beyond standard medical device protocols. Clinicians should follow general guidelines for handling and storing dental implants, such as maintaining sterility, protecting from contamination, and adhering to manufacturer-recommended conditions to preserve functionality and safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Paltop Implants - Keystone Dental Group, K232740 - Paltop Short Implants - Dental, Paltop Implants - Keystone Dental Group International, PDF Paltop Advanced Dental Solutions, Ltd Zina Gurgov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Paltop Advanced Dental Solutions, Ltd.

Sources (1)

  • FDA 510(k) K232740 24 fields · synced Oct 5, 2026