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510(k) Data Aggregation

    K Number
    K041335
    Device Name
    PTM SYSTEM
    Manufacturer
    DENTSPLY INTERNATIONAL
    Date Cleared
    2004-06-16

    (29 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K940252
    Why did this record match?
    Reference Devices :

    K940252

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Used to veneer metal substructures for fixed prosthodontics

    Device Description

    The PTM™ SYSTEM is a press to metal system that consists of dental ceramic veneering materials designed for use in fixed prosthodontics devices that include both anterior and posterior crowns/bridges.

    The PTM™ SYSTEM consists of an Opaque porcelain, Dentin/Enamel translucent ingots, Enamel Effect Porcelains, and a Glaze/Stain porcelain.

    AI/ML Overview

    The provided 510(k) summary for the DENTSPLY PTM™ SYSTEM does not contain information on acceptance criteria or a study proving that the device meets such criteria. This document is a premarket notification for a dental ceramic veneering material, focusing on demonstrating substantial equivalence to a predicate device rather than presenting performance study results against predefined acceptance criteria.

    The information typically found in a 510(k) summary relates to the device's description, intended use, technological characteristics, and comparison to a predicate device. It usually does not include detailed clinical or performance study data with acceptance criteria, sample sizes, ground truth establishment, or expert adjudication methods as would be present for a novel or higher-risk device requiring such evidence.

    Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

    The document states:

    • "We believe that the prior use of the components in legally marketed devices, the similarity in the formulations between the modified device and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of the PTM™ SYSTEM for the intended use."

    This statement indicates that the submission relies on the established safety and effectiveness of a predicate device and the minor nature of the changes, rather than a new performance study with explicit acceptance criteria.

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