LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K191034
    Device Name
    VPS Impression Material
    Manufacturer
    Hygedent Inc.
    Date Cleared
    2019-09-04

    (139 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K133071,K040053
    Why did this record match?
    Reference Devices :

    K133071

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

    VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

    Device Description

    VPS Impression Material is dental Impression Material. It complies with the requirements of ISO 4823:2015 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge. The VPS Impression Material package includes four dual-barrel 50ml cartridges.

    AI/ML Overview

    The provided text is a 510(k) summary for a dental impression material. The document demonstrates substantial equivalence to predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding study details and expert adjudication is not present in this document.

    However, I can extract the acceptance criteria and performance data for the device based on the non-clinical performance tests presented.

    Here's the information derived from the document:

    1. A table of acceptance criteria and the reported device performance

    Physical ParametersAcceptance Criteria (Standard ISO4823)Reported Device Performance (K191034)
    Consistency≤35mm31 mm
    Working time≥1'30"2'
    Detail reproduction50μmcomplies (implicitly meets 50μm)
    Linear dimensional change≤1.5%0.16%
    Compatibility with gypsum50μmcomplies (implicitly meets 50μm)
    Elastic recovery≥96.5%99.06%
    Strain-in-compression>0.8%
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1