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510(k) Data Aggregation

    K Number
    K003427
    Date Cleared
    2001-01-24

    (82 days)

    Product Code
    Regulation Number
    872.3275
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ZINC PHOSPHATE CEMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K983018
    Manufacturer
    Date Cleared
    1998-10-22

    (55 days)

    Product Code
    Regulation Number
    872.3275
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ZINC PHOSPHATE CEMENT

    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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    K Number
    K982913
    Date Cleared
    1998-10-19

    (61 days)

    Product Code
    Regulation Number
    872.3275
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ZINFOS ZINC PHOSPHATE CEMENT

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

    For permanent cementation of Crowns and bridges on non-vital teeth and on vital teeth where the use of Conventional Zinc Phosphate Cements is judged appropriate.

    Device Description

    ZinFos Zinc Phosphate Cement

    AI/ML Overview

    The provided document is a 510(k) clearance letter for a medical device called "ZinFos Zinc Phosphate Cement." This document is not a study report and therefore does not contain the information requested in the prompt.

    The prompt asks for details about acceptance criteria and a study proving device performance, typically found in a clinical or performance assessment report for a device, especially for those involving AI or diagnostic capabilities. The ZinFos Zinc Phosphate Cement is a traditional dental cement, and its regulatory clearance would be based on substantial equivalence to predicate devices, rather than a performance study as described in the prompt's questions.

    Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, or ground truth details from the given text.

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