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510(k) Data Aggregation

    K Number
    K140602
    Device Name
    FLASH PENTA MB QUICK, FLASH MB QUICK
    Manufacturer
    3M ESPE AG
    Date Cleared
    2014-06-05

    (87 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K120438
    Why did this record match?
    Device Name :

    FLASH PENTA MB QUICK, FLASH MB QUICK

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

    All types of impressions, e.g .:
    · Crown, bridge, inlay, and onlay preparations
    · Implants
    · Orthodontic impressions

    Device Description

    Flash Penta™ MB Quick and Flash MB Quick are addition type silicone impression materials of medium consistency. Flash Penta MB Quick is mixed in the Pentamix mixing device, while Flash MB Quick can be applied directly using the Garant™ dispenser. Both products are used in mono-phase technique and in one-step technique.

    AI/ML Overview

    The provided text describes a 510(k) submission for dental impression materials (Flash Penta™ MB Quick and Flash MB Quick). It primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical properties. However, it does not contain the detailed information requested regarding acceptance criteria, study design for proving device acceptance, or any elements related to AI/algorithm performance.

    Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about sample sizes, ground truth, experts, or MRMC studies as these are not mentioned in the provided document.

    To be specific about what is mentioned:

    • Device: Flash Penta™ MB Quick and Flash MB Quick (VPS impression material).
    • Study Type: Bench testing.
    • Properties Evaluated: Consistency, total working time, detail reproduction, linear dimensional change, compatibility with gypsum type 3 / type 4, recovery from deformation and strain in compression.
    • Purpose: To demonstrate substantial equivalence to predicate devices (Flash Penta™ HB Q, Flash Heavy Body Q, Flash Regular Body Q, Flash Light Body) in terms of intended use, indications for use, composition, and physical properties.

    The document states that a "biocompatibility assessment was developed... using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines" and concluded that the products are safe for their intended use. However, no specific details of this assessment's methods or results are provided.

    In summary, the provided document does not contain the information necessary to fulfill your request for details on acceptance criteria, a study proving device acceptance, or any AI/algorithm-related performance metrics.

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