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510(k) Data Aggregation

    K Number
    K233859
    Device Name
    BASIS FLOW II
    Manufacturer
    Yamahachi Dental MFG., Co.
    Date Cleared
    2024-03-05

    (90 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K131036
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BASIS FLOW II is intended for fabrication or repair of the denture base.

    Device Description

    BASIS FLOW II is supplied as components in powder and liguid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) with small quantities of initiator and color pigments. The liquid is primarily the monomer methyl methacrylate (MMA) with small quantities of a cross-linking agent and activator.

    To fabricate the denture base, the powder and liguid materials are mixed and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures in a self-curing process (pressure vessel or via quick-setting).

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA regarding a dental resin, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement for an AI/ML device is not applicable and cannot be extracted from this document.

    The document discusses the substantial equivalence of BALANCE FLOW II (subject device) to BALANCE FLOW (predicate device) based on physical and chemical properties and adherence to ISO standards for denture base polymers.

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