LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983223
    Device Name
    DENTAL STERLIZATION TRAY/CASSETTE
    Manufacturer
    BRASSELER USA I, L.P.
    Date Cleared
    1999-01-14

    (122 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DENTAL STERLIZATION TRAY/CASSETTE

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

    This is intended to enclose medical devices that are to be sterilized in a health care facility. The tray is intended to allow steam to penetrate to the enclosed medical devices.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a "Dental Sterilization Tray/Cassette". This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily addresses the regulatory classification and premarket notification status of the device, confirming its substantial equivalence to a legally marketed predicate device.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1