LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K151646
    Device Name
    ProTech Plus
    Manufacturer
    PROTECH PROFESSIONAL PRODUCTS, INC.
    Date Cleared
    2015-10-21

    (125 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Protech's Plus and Soft Reline resins are intended to be used for relining a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for a dental device, "ProTech Plus." It does not contain any information about acceptance criteria, device performance studies, or data provenance related to AI/ML devices.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this document pertains to a traditional medical device (denture relining, repairing, or rebasing resin) and not an AI-powered device.

    The letter simply states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1