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510(k) Data Aggregation

    K Number
    K150454
    Device Name
    Acryfree Denture Base Material and Biosens Denture Base Material
    Manufacturer
    PERFLEX
    Date Cleared
    2015-05-26

    (95 days)

    Product Code
    EBI,MQC
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K213994
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    "Acryfree Denture Base Material" and "Biosens Denture Base Material" are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, personal trays, appliances, occlusal splints and night guards.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for denture base materials. It does not contain information about the acceptance criteria or a study proving that the device meets acceptance criteria. The document confirms that the devices are substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. It also includes the "Indications for Use" for the devices.

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

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