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510(k) Data Aggregation

    K Number
    K251926

    Validate with FDA (Live)

    Device Name
    enCore Impression Material
    Manufacturer
    Encore Guards
    Date Cleared
    2026-03-17

    (267 days)

    Product Code
    SHI
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K092319,K213244
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EnCore Impression Material is intended for dental impression techniques to reproduce the structure of a patient's dentition to fabricate patient matched night guards and mouthguards.

    Device Description

    The EnCore Impression Material is an addition-cure impression material composed of vinyl polysiloxane impression and bite registration materials intended to allow dentists to take accurate impressions.

    AI/ML Overview

    N/A

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