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510(k) Data Aggregation

    K Number
    K190571
    Device Name
    StoneBite and StoneBite scan
    Manufacturer
    Dreve Dentamid GmbH
    Date Cleared
    2019-11-07

    (246 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K171562,K081017,K021410,K053427,K081120
    Why did this record match?
    Reference Devices :

    K171562, K081017, K021410, K053427

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

    StoneBite® and StoneBite® scan are addition-curing silicones for bite registrations.

    StoneBite® is indicated for:

    • bite registrations
    • I key for intraoral registration

    StoneBite® scan is indicated for:

    • i bite registrations
    • key for intraoral registration
    • . optical collection of data in CAD/CAM/CIM systems
    Device Description

    StoneBite and StoneBite scan are addition-curing silicones for bite registration, used in dental applications to produce an accurate reproduction of the patient's occlusal record.

    StoneBite and StoneBite scan are vinyl polysiloxane based materials.

    StoneBite and StoneBite scan are medium-body elastomeric bite registration materials for dental applications to produce an accurate reproduction of the patient's occlusal record. StoneBite and StoneBite scan are two-component (base and catalyst) additioncuring materials.

    AI/ML Overview

    The document describes the non-clinical performance testing for dental impression materials, specifically StoneBite and StoneBite scan. This is not medical AI device and therefore does not contain any of information requested.

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