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510(k) Data Aggregation

    K Number
    K003427
    Device Name
    ZINC PHOSPHATE CEMENT
    Manufacturer
    RITE-DENT MANUFACTURING CORP.
    Date Cleared
    2001-01-24

    (82 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K983018
    Device Name
    ZINC PHOSPHATE CEMENT
    Manufacturer
    MEDENTAL INTL.
    Date Cleared
    1998-10-22

    (55 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Zinc phosphate cement is without any adhesive properties and is used as a luting agent. It is always referred to as a cement and is used for the attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets.

    Device Description

    Zinc Phosphate is the oldest of the cementation agents and thus the one with the longest track record (introduced in 1878). It serves as a standard by which newer systems can be compared. It consists of powder and liguid in two separate bottles. The main ingredients of the powder are zinc oxide and magnesium oxide. The liquid contains phosphoric acid, distilled water, alumina hydrate, and zinc oxide. Zinc phosphate cement is without any adhesive properties and is used as a luting agent. It is always referred to as a cement and is used for the attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a Zinc Phosphate Cement and contains no information about acceptance criteria or a study proving that a device meets those criteria. The document is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the requested information.

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