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    K Number
    K052090
    Device Name
    SPLASH! IMPRESSION MATERIAL DEVICE
    Manufacturer
    DISCUS DENTAL INC.
    Date Cleared
    2005-08-05

    (3 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K040053,K030318,K021416
    Why did this record match?
    Device Name :

    SPLASH! IMPRESSION MATERIAL DEVICE

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

    Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

    Device Description

    Splash!® Dental Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material. It is available in Regular set or fast-setting Half-time varieties. Both are available in a heavy viscosity and in wild berry flavor, as well as unflavored.

    AI/ML Overview

    Here's an analysis of the provided information regarding the Splash!® Dental Impression Material, focusing on acceptance criteria and the supporting study details:

    Device: Splash!® Dental Impression Material

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Splash!® Dental Impression Material are primarily based on demonstrating substantial equivalence to predicate devices across various physical and chemical properties relevant to dental impression materials. The "acceptance criteria" are implied by the ranges and values observed in the predicate devices which the new device aims to meet or perform comparably to.

    PropertyAcceptance Criteria (Implied from Predicates)Splash!® Dental Impression Material Performance
    Material Type (ISO 4823)Type 0-3 (Consistent with Precision) or Type 1-3 (Aquasil, P2 Polyether)Type 0-3
    Recovery from Deformation>98.0% (Aquasil) or 97.5% - 99.6% (P2, Precision)99.2% - 99.5%
    Shrinkage
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