LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K131510
    Device Name
    POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
    Manufacturer
    BLACKWELL DEVICE CONSULTING
    Date Cleared
    2013-12-20

    (210 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

    Polydimethylsiloxane Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Regular Set material is used for capturing multiple unit restorations. Fast Set is used for capturing one preparation only(single unit crown) and is ideal for double arch dual phase techniques.

    Device Description

    Polydimethylsiloxane Impression Material

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a Polydimethylsiloxane Impression Material. It does not contain any information regarding acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device studies.

    The content is a regulatory approval letter, confirming the substantial equivalence of the impression material to previously marketed devices and outlining the applicable regulations. It is not a detailed clinical or performance study report.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1