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510(k) Data Aggregation

    K Number
    K030776
    Device Name
    MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
    Manufacturer
    DISCUS DENTAL, INC.
    Date Cleared
    2003-05-09

    (59 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL

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

    Mega Bite is designed for making accurate occlusal records.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental impression material called "Mega Bite Registration." It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    The letter is primarily a regulatory communication stating that the device can be marketed. It does not detail the technical performance or the studies conducted to establish substantial equivalence.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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