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510(k) Data Aggregation

    K Number
    K073568
    Device Name
    PSL BIOZIR BLOCK
    Manufacturer
    P.S.L. INTERNATIONAL INC.
    Date Cleared
    2008-02-06

    (48 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K950299,K972276,K050903,K043472,K023327,K984201
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.

    Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

    Device Description

    PSL BioZir Block™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. PSL BioZir Block™ (when it reaches the dentist, like opercelain "powder" prepared by the laboratory into an inlay or onlay, or as a bridge or crown) is a finished device ready for installation. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay, onlay, or crown inprepsived or modern computerized lathe methods and returned to the dentist then prepares the final tooth surfaces involved and cements (lutes) the prosthesis in place with standard departs adle timal (luting) materials. PSL BioZir Block™ prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcely inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-onage, for ready visualization.

    AI/ML Overview

    The provided 510(k) summary does not contain information about acceptance criteria or a study demonstrating the device's performance against such criteria. This document describes a dental restorative material, PSL BioZir Block™, and establishes its substantial equivalence to previously cleared devices based on intended use, technological characteristics, and material composition.

    Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text.

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