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    K Number
    K131504
    Device Name
    UNIVERSAL OPAQUE
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2013-07-16

    (53 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    UNIVERSAL OPAQUE is a light-curing resin paste to be used for masking the substructure color of dental restorations.

      1. Masking the metal color of facing crown
      1. Masking the substructure color of jacket crown and laminate veneer etc.
      1. Masking the substructure color of restorations and prostheses made of porcelain or crown and bridge composite resin etc. when repairing them intraorally or extraorally.
    Device Description

    UNIVERSAL OPAQUE is a light-curing resin paste.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental device named "Universal Opaque." However, it is a Premarket Notification document from the FDA, which is a submission to demonstrate substantial equivalence to a legally marketed predicate device. This type of document does not typically contain acceptance criteria or detailed study results like those requested in the prompt.

    Therefore,Based on the provided text, there is no information available regarding acceptance criteria, device performance, or any studies conducted as outlined in your request. The document is an FDA 510(k) clearance letter confirming that "Universal Opaque" is substantially equivalent to a predicate device for its stated indications for use. It outlines regulatory compliance but does not present the specific technical data or clinical study details you are asking for.

    To answer your questions, one would need access to the full 510(k) submission, which is not included in this document.

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