LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012405
    Device Name
    EXTRUDE MODIFIED
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2001-09-04

    (36 days)

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

    EXTRUDE MODIFIED

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

    Extrude Modified is a multiviscosity polyvinylsiloxane impression material system suitable for all crown and bridge, edentulous and implant impression techniques.

    Device Description

    Extrude Modified is a multiviscosity polyvinylsiloxane impression material system suitable for all crown and bridge, edentulous and implant impression techniques. Extrude Modified is a two-part, base/catalyst - paste/paste system. The two-part system is packaged either in tubes or cartridges. The product is available in three viscosities, Wash, Medium and Extra.

    AI/ML Overview

    This document is a 510(k) summary for Extrude Modified, a dental impression material. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. It is a regulatory submission for premarket notification, claiming substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1