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    K Number
    K981091
    Device Name
    NEOCOLLOID, ORTHOPRINT
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    1998-05-21

    (57 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEOCOLLOID, ORTHOPRINT

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

    Neocolloid and Orthoprint are alginate dental impression materials that are intended to be used to make dental impressions. The resulting impressions are used to make plaster models of the teeth.

    Device Description

    Neocolloid and Orthoprint are alginate dental impression materials.

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for a dental impression material. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot generate a response based on your request.

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