Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K984587
    Date Cleared
    1999-03-17

    (83 days)

    Product Code
    Regulation Number
    872.3060
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALLROUND-E (CODE NAME RD 1710)

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

    Allround E ( Code name: RD1710 ) is a platinum gray color, Copper free, palladium-silver, porcelain-to-metal alloy designed for low fusing porcelain in the market. It is a Noble alloy under Identalloy and ADA classification system for Dental alloy. It can also be used as Type-III crown and bridge alloy. It is suitable for single units, short--span bridge work and long span bridge work. Ideal for combination cases of PTM / PFM and Crowns.

    Device Description

    Allround E ( Code name: RD1710 ) is a platinum gray color, Copper free, palladium-silver, porcelain-to-metal alloy designed for low fusing porcelain in the market. It is a Noble alloy under Identalloy and ADA classification system for Dental alloy. It can also be used as Type-III crown and bridge alloy. It is suitable for single units, short--span bridge work and long span bridge work. Ideal for combination cases of PTM / PFM and Crowns.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental alloy named "Allround-E (Code Name RD 1710)". It does not contain information about acceptance criteria or a study proving that a device meets such criteria.

    The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."

    This means the device was cleared based on its substantial equivalence to pre-existing, legally marketed devices, not through a study demonstrating it meets specific performance acceptance criteria.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1