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510(k) Data Aggregation

    K Number
    K052699
    Device Name
    VERSA-LINK PORCELAIN BONDING SYSTEM
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    2005-11-16

    (49 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VERSA-LINK PORCELAIN BONDING SYSTEM

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

    Versa-Link Porcelain Bonding System is indicated for the adhesive cementation/bonding of all-ceramic dental restorations (veneers, inlays, onlays and crowns) composed of feldspathic porcelain, pressed porcelain and in-office machined ceramics.

    A secondary indication is for the adhesive repair of fractured or damaged metal-ceramic units intraorally.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental bonding system. It does not contain any information about the acceptance criteria, study details, or performance evaluation of a device as requested in the prompt.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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