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510(k) Data Aggregation

    K Number
    K973548
    Device Name
    MERCURY DENTAL
    Manufacturer
    ALEACIONES DENTALES ZEYCO, S.A. DE C.V.
    Date Cleared
    1998-03-23

    (186 days)

    Product Code
    ELY
    Regulation Number
    872.3070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEACIONES DENTALES ZEYCO, S.A. DE C.V.

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

    IS USED TO MIX WITH A SILVER-TIN-COPPER POWDER ALLOY TO MAKE A DENTAL AMALGAM AND THEN TO FILL DENTAL CAVITIES

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding a dental amalgam. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from the provided text.

    The letter simply states that the FDA has reviewed the notification for the device named "Mercury Dental" and determined it to be "substantially equivalent" to devices marketed prior to May 28, 1976. This substantial equivalence determination allows the company, Aleaciones Dentales Zeyco, S.A. de C.V., to market the device.

    The document provides the following details, but none are related to device performance studies or acceptance criteria:

    • Trade Name: Mercury Dental
    • Regulatory Class: I
    • Product Code: ELY
    • Indications For Use: "IS USED TO MIX WITH A SILVER-TIN-COPPER POWDER ALLOY TO MAKE A DENTAL AMALGAM AND THEN TO FILL DENTAL CAVITIES"
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