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510(k) Data Aggregation

    K Number
    K970129
    Device Name
    TULIP
    Manufacturer
    RICHARD TING
    Date Cleared
    1997-08-18

    (215 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    THE DENTAL ALGINATE IMPRESSION MATERIAL IS JSED TO TAKE THE PATIENT'S IMPRESSIONS OF TEETH AND GUM WHEN THE PATIENT NEEDS DEVIURE, PARTIAL, OR ANY KINDS OF DENTAL APPLIANCES AND ORTHODONTIC APPLIANCES.

    Device Description

    DENTAL ALGINATE IMPRESSION MATERIAL

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a dental alginate impression material from 1997. It describes the regulatory approval of the device but does not contain any information about acceptance criteria, study data, performance metrics, or details of a study used to prove the device meets acceptance criteria.

    Therefore, I cannot extract the requested information.

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