LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012307
    Device Name
    LUXACORE/LUXACORE DUAL
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2001-08-23

    (31 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K932826,K872510,K964000,K982201
    Why did this record match?
    Device Name :

    LUXACORE/LUXACORE DUAL

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

    The principal use for LuxaCore and LuxaCore Dual is as a core material either with adhesives or with pins or posts.

    LuxaCore and LuxaCore Dual can also be used for:

    • . Luting of abutments to dentures (LuxaCore)
    • . Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
    • . Repair material for provisionals
    • . Bite registration material.
    • . Build up material for plastic bite rails (occlusal individualisation).
    • . Cement for pins and posts
    • . Semipermanent restorative material (e.g., in childrens' teeth)
    Device Description

    LuxaCore: LuxaCore is a chemical-curing, radiopaque two-component core build-up material supplied in automix delivery systems or as a handmix material.

    LuxaCore Dual: LuxaCore Dual is a dual cure (chemical and/or light cure), radiopaque two-component core build-up material supplied in automix delivery systems or as a handmix material

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for dental materials (LuxaCore / LuxaCore Dual) and does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of an AI/medical imaging device.

    Specifically, the document:

    • Describes dental core build-up and restorative materials.
    • Identifies predicate devices for substantial equivalence.
    • Lists indications for use for the dental materials.
    • States it's an Abbreviated 510(k) and references conformity with FDA guidance for "Dental Composites - Premarket Notification."
    • Concludes the materials are "safe and effective for their intended use" based on technological characteristics and comparison to predicate devices.
    • Includes correspondence from the FDA confirming substantial equivalence.

    There is no mention of:

    • Acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) for an AI device.
    • Any study that tests an AI algorithm's performance against such criteria.
    • Sample sizes for test or training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or types of ground truth relevant to AI performance evaluation.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI device meets them based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1