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510(k) Data Aggregation

    K Number
    K961089
    Device Name
    PULPDENT ENDOPREP II
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    1996-04-23

    (35 days)

    Product Code
    EKL
    Regulation Number
    872.3840
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K934415,K950365,K896663,K932791
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.

    Device Description

    PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin. PULPDENT Endo-Prep II will be offered in two viscosities, thin and thick, so that the dentist can apply the product either directly to the canal ovening or to the file.

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a "SUMMARY OF SAFETY AND EFFECTIVENESS DATA" for a dental product called PULPDENT Endo-Prep II, which is a chelating agent used in root canal procedures.

    The document focuses on comparing PULPDENT Endo-Prep II to predicate devices, stating its substantial equivalence in composition and intended use. It references a publication by the American Dental Association regarding the general effectiveness of EDTA as a chelating agent.

    Therefore, I cannot fulfill the request to describe acceptance criteria and a study based on the provided text, as this information is not present.

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