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510(k) Data Aggregation

    K Number
    K143758
    Device Name
    PerioType Rapid
    Manufacturer
    CLINICAL HOUSE EUROPE GMBH
    Date Cleared
    2015-08-07

    (219 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PerioType Rapid

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

    PerioType Rapid Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients for loading after healing or immediate loading provided that stability requirements are satisfied.

    Device Description

    PerioType Rapid Implants are threaded, root-form dental implants

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental implant device called "Periotype Rapid." This document does not contain information about acceptance criteria, device performance, study details for a test set, ground truth for training or testing, or a multi-reader multi-case comparative effectiveness study. It primarily focuses on the device's substantial equivalence to predicate devices and the regulatory framework.

    Therefore, I cannot extract the requested information from the given text. The text does not describe a study that proves the device meets specific acceptance criteria in the context of AI/ML performance metrics.

    The document states:

    • Trade/Device Name: Periotype Rapid
    • Regulation Number: 21 CFR 872.3640
    • Regulation Name: Endosseous Dental Implant
    • Regulatory Class: Class II
    • Product Code: DZE
    • Indications for Use: PerioType Rapid Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients for loading after healing or immediate loading provided that stability requirements are satisfied.
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