Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K251926

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-17

    (267 days)

    Product Code
    Regulation Number
    872.3660
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    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

    Ask a Question

    Ask a specific question about this device

    K Number
    K252004

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-25

    (151 days)

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

    The enCore Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

    Device Description

    The enCore Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1