LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993710
    Device Name
    MODIFICATION OF PARAPOST CEMENT
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    1999-12-21

    (48 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K945366
    Why did this record match?
    Device Name :

    MODIFICATION OF PARAPOST CEMENT

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

    ParaCem cement is for the discretionary use by dentists for the permanent cementation of endodontic posts into root canals after endodontic therapy has been completed.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental cement product. It does not contain information about a device that uses artificial intelligence or machine learning, nor does it describe any acceptance criteria or studies related to AI/ML device performance.

    Therefore, I cannot provide the requested information. The provided text is a regulatory approval document for a traditional medical device, not an AI/ML-driven one.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1