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510(k) Data Aggregation

    K Number
    K993324
    Device Name
    CARBOCEM ZINC POLYCARBOXYLATE CEMENT
    Manufacturer
    SCIENTIFIC PHARMACEUTICALS, INC.
    Date Cleared
    1999-11-09

    (36 days)

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

    CARBOCEM ZINC POLYCARBOXYLATE CEMENT

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

    For temporary or permanent cementation of crowns and bridges on non-vital and vital teeth where retention is of primary concern. Also for use as temporary filling material.

    Device Description

    Carbocem Zinc Polycarboxylate Cement

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental cement called Carbocem. It does not contain information about acceptance criteria or a study proving device performance in the context of the questions asked. The questions appear to be geared towards AI/ML device evaluations, which is not applicable to this traditional medical device clearance.

    Therefore, I cannot provide the requested information based on the provided text.

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