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510(k) Data Aggregation

    K Number
    K152349
    Device Name
    Star+ VPS Scannable Impression Material
    Manufacturer
    DANVILLE MATERIALS LLC
    Date Cleared
    2015-11-23

    (95 days)

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

    Star+ VPS Scannable Impression Material

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

    Star+ VPS Scannable Impression Material is an addition-cured vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, and implant techniques. The impression material can also be scanned by dental impression scanners

    Device Description

    Star+ VPS Scannable Impression Material is an addition-cured vinyl polysiloxane dental impression material.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and study proving device performance. The document is an FDA 510(k) clearance letter for a dental impression material, and it primarily focuses on the regulatory approval process and indications for use, rather than detailed performance study results.

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