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510(k) Data Aggregation

    K Number
    K073475
    Device Name
    SYSTEM PLUS
    Manufacturer
    CONTINENTAL DENTAL LABORATORY
    Date Cleared
    2008-03-10

    (90 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K052090
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    System Plus is a vinyl polysiloxane dental impression material. It is ideal for one-step impressions to reproduce the structure of a patient's teeth and gums to produce crowns, bridges, inlays, partial and complete dentures, denture repairs, implants and other dental restorations prescribed by a dentist.

    Device Description

    System Plus is an addition-reaction silicone impression material. This vinyl polysiloxane (VPS) impression material comes in two different viscosities intended to help reproduce the structure of a patient's teeth and gums in order to produce, crowns, bridges, implants, and other dental restorations.

    AI/ML Overview

    The provided text describes the "System Plus Impression Material," a dental impression material. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive clinical study. Therefore, some of the requested information, particularly regarding studies with human participants, AI performance, and expert consensus for ground truth, is not applicable or present in this type of submission.

    Here's a breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The acceptance criteria are established by comparing the physical properties of the System Plus Impression Material to a predicate device (Splash! - Discus Dental, Inc.) and relevant ISO standards (ISO 4823). The table below summarizes the key properties and their values for the System Plus material. The "acceptance criteria" are implied by demonstrating comparable performance to the predicate and meeting standard ranges.

    PropertyAcceptance Criteria (Implied by Predicate/ISO)Reported Device Performance (System Plus)
    Consistency, ISO 4823Type 0-3 (Splash! range)Medium Body: Type 2
    Light Body: Type 3
    Strain in Compression %
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