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510(k) Data Aggregation

    K Number
    K003373
    Device Name
    PROCAD ADD-ON
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2000-11-28

    (29 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROCAD ADD-ON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K980986
    Device Name
    PROCAD
    Manufacturer
    IVOCLAR USA, INC.
    Date Cleared
    1998-05-11

    (55 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROCAD

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

    Intended Use: ProCad is intended to be used for inlays, onlays, veneers, and anterior/posterior crowns.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device called "ProCad". It does not contain information about acceptance criteria, study details, or performance data for the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for its intended use, which are "inlays, onlays, veneers, and anterior/posterior crowns."

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