LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K242014

    Validate with FDA (Live)

    Device Name
    Jet Flow Bulk
    Manufacturer
    META Biomed Co., Ltd.
    Date Cleared
    2024-10-08

    (90 days)

    Product Code
    EBF,EBC
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K120453
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Base under Class I and II direct restorations
    • Pit and fissure sealant
    • Class III and V restorations
    • Repair of resin, porcelain and acrylic temporary materials
    • Liner under direct restorative materials
    Device Description

    Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent enabling up to a depth of 3~5mm at a time. Jet Flow Bulk is packaged in disposable tips and two syringes that include restorative materials. The shades offered with Jet Flow Bulk are Universal(U), Dentin(D), A1, A2, A3. Jet Flow Bulk contains bisGMA, UDMA, bisEMA. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.053 to 6.76 microns and silica with a particle size range of 0.04 to 0.452 um. The inorganic filler loading is approximately 35.6 vol.% (61.0wt.%).

    AI/ML Overview

    The document provided is a 510(k) premarket notification clearance letter for a dental device, "Jet Flow Bulk." It does not contain information about an AI/ML device or its performance characteristics in the context of a clinical study or acceptance criteria related to software performance. The acceptance criteria and "study" described in the document are for material properties and biocompatibility of a dental resin, not for an AI algorithm.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for "the device" as requested by the user, because the provided text is about a physical dental material and not an AI-powered medical device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1