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510(k) Data Aggregation

    K Number
    K182296
    Device Name
    HyperFil-LV
    Manufacturer
    Parkell, Inc.
    Date Cleared
    2018-12-14

    (112 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K010475,K062518
    Why did this record match?
    Reference Devices :

    K010475

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

    HyperFil®-LV is a dual-cure, tooth shade, resin composite which is indicated for Class I, II, III, IV, and V restorations, including root surface cavities, post cementing, and core build-ups.

    Device Description

    HyperFil®-LV is a dual-cure, highly radiopaque, flowable, bulk-fill composite restorative material suitable for direct and indirect restorations. HyperFil®-LV is light-curable to a depth of about 3-4 mm in 40 seconds with a dental curing light emitting at 430 - 480 nm with an intensity of >600 mW/cm². It will also self-cure to any depth in about 4-5 minutes at mouth temperature. HyperFil®-LV contains a combination of filling agents which give restorations constructed with HyperFil®-LV high compressive, tensile, and flexural strength. HyperFil®-LV will be packaged in single dual-chamber 5 mL syringes. The device comprises catalyst and base components, which are combined just prior to use via a mixing tip which is affixed to the dual chamber syringe.

    AI/ML Overview

    This document, a 510(k) summary for the medical device HyperFil-LV, does not contain information related to an AI/ML device study. Instead, it describes a dental resin composite and its equivalence to a predicate device based on physical and chemical properties. Therefore, I cannot provide details on acceptance criteria, test sets, expert ground truth establishment, or clinical performance related to AI/ML as these are not present in the provided text.

    The document discusses the following non-AI related aspects:

    1. A table of acceptance criteria and the reported device performance:

    Property (pass/fail criteria, if applicable)Acceptance Criteria for Predicate Device (Celerity)Reported Device Performance (HyperFil®-LV)
    Compressive Strength>300 MPa>300 MPa
    Flexural Strength>100 MPa>100 MPa
    Tensile Strength>40 MPa>40 MPa
    Depth of Cure>1 mm>1 mm
    Modulus of Elasticity>10 GPa>10 GPa
    Radiopacity>200%>200%
    Water Sorption
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