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510(k) Data Aggregation

    K Number
    K012744
    Device Name
    INTRAORAL LENS OPTION TO SPECTROSHADE
    Manufacturer
    MHT OPTIC RESEARCH AG
    Date Cleared
    2002-01-23

    (160 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SpectroShade's intraoral lens option is an accessory imaging device, which is intended for use by dental professionals in taking intraoral images of dental anatomy in order to:

      1. Assist in the assessment of the overall patient's dental health by providing magnified digital images of the oral cavity.
      1. Provide visual educational information to the patient to more effectively communicate a treatment plan.
      1. Provide documented images for patient records, insurance companies, and other dental professionals.
      1. Allow the practitioner to display before and after images of dental procedures.
    Device Description

    Intraoral Lens Option To SpectroShade

    AI/ML Overview

    I am sorry, but based on the provided document, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available. The document is a 510(k) clearance letter for an intraoral lens option, which focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results with specific acceptance criteria.

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