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510(k) Data Aggregation

    K Number
    K221909
    Device Name
    J-Temp
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2022-07-01

    (1 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K033665,K210349,K153493
    Why did this record match?
    Reference Devices :

    K033665, K210349

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

    •Temporary restorations
    •Splinting between implant copings for impressions to resist impression material distortion
    •To provide structure for isolation clamping and to act as a barrier for endodontic irrigants
    • Bite ramps and temporary occlusal buildups during orthodontics

    Device Description

    J-Temp temporary resin is a flowable resin material designed to be durable enough to stay in place after being applied. It is delivered via syringe and light cured.

    AI/ML Overview

    This document does not contain information about acceptance criteria and study details for device performance. It is an FDA 510(k) premarket notification for a dental resin material named "J-Temp", primarily focusing on its substantial equivalence to a predicate device ("Clip Flow" by Voco).

    While a table comparing technological characteristics is provided, it outlines similarities and differences between the new device and predicate devices in terms of intended use, composition, physical properties, etc. However, this table does not include:

    • Specific acceptance criteria (e.g., numerical thresholds for performance metrics).
    • Reported device performance against such criteria.
    • Details about a study designed to prove the device meets acceptance criteria, including sample sizes, ground truth establishment, expert involvement, or comparative effectiveness.

    The document states that the device "successfully passed all verification and validation testing," but it does not provide any specifics about these tests, the acceptance criteria used, or the results obtained.

    Therefore, I cannot provide the requested information from the given text.

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