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510(k) Data Aggregation

    K Number
    K173500
    Device Name
    NMF004A
    Manufacturer
    GC America Inc.
    Date Cleared
    2018-03-08

    (115 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K123631,K082434,K091388
    Why did this record match?
    Device Name :

    NMF004A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Liner or base
    2. Blocking out undercuts
    3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins are in enamel
    4. Sealing hypersensitive areas
    5. Fissure sealant
    6. Direct restorative for Class I, II, III, IV, V cavities
    7. Core build-up
    Device Description

    NMF004A is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is used for the restorations of both anterior and posterior teeth. The material is available in 30 shades.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental device named NMF004A. This document asserts the device's substantial equivalence to previously cleared predicate devices by outlining its characteristics, indications for use, and performance bench tests against a recognized standard (ISO 4049:2009).

    Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

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

    The document states that "The applicant device complies with all the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative materials)." While specific measured values for NMF004A are not explicitly provided in the table, the text implies that NMF004A's performance meets these requirements. The table below presents the acceptance criteria from ISO 4049:2009 as listed in the document.

    PropertyAcceptance Criteria (from ISO 4049:2009)Reported Device Performance (NMF004A)
    Sensitivity to ambient lightRemain physically homogeneousComplies
    Depth of cureOpaque shade: > 1.5mm
    Other shade: > 2.0mmComplies
    Flexural strength> 80 MPaComplies
    Water sorption
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