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510(k) Data Aggregation

    K Number
    K112397
    Device Name
    ORTHO-JET CRYSTAL
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    2011-11-04

    (77 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ORTHO-JET CRYSTAL

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

    Lang Dental Ortho-Jet Crystal, Clear Acrylic Resin is intended for the fabrication of methacrylate-based orthodontic appliances and is intended for use when aesthetically clear acrylic appliances, such as orthodontic retainers, are desired.

    Device Description

    Lang Dental Ortho-Jet Crystal, Clear Acrylic Resin

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a dental resin, not a study evaluating a device's performance against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) cannot be extracted from this document.

    The document is a clearance letter stating that the Lang Dental Ortho-Jet Crystal, Clear Acrylic Resin is substantially equivalent to legally marketed predicate devices. It describes the product's intended use and the regulatory framework it falls under. It does not contain any performance data or a study description.

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