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510(k) Data Aggregation

    K Number
    K172560
    Device Name
    PREMIUM ONE Implant Systems
    Manufacturer
    Sweden & Martina S.p.A
    Date Cleared
    2017-12-21

    (118 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PREMIUM ONE Implant Systems are intended for both one- and two-stage surgical procedures. PREMIUM ONE Implant Systems are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the "PREMIUM ONE Implant Systems" does not contain information about acceptance criteria or the study that proves the device meets those criteria. This document is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device, and outlines regulatory requirements and contact information. It does not elaborate on performance studies or acceptance criteria.

    Therefore, I cannot provide the requested information based on the given input.

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