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510(k) Data Aggregation

    K Number
    K252285
    Device Name
    Well-Root PT
    Manufacturer
    Vericom Co., Ltd.
    Date Cleared
    2025-09-19

    (58 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K092715,K142178
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Pulp Capping
    • Repair of Root Perforation
    • Repair of Root Resorption
    • Root-end Filling
    • Apexification
    Device Description

    Well-Root PT is ready-to use, premixed, bioceramic paste developed for pulp capping, permanent root canal repair and filling. Well-Root PT is delivered by the capsule containing the mixture of calcium silicate cement, liquid and several compound particles. It sets in the root without the mixing process with additional water.

    AI/ML Overview

    N/A

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