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510(k) Data Aggregation

    K Number
    K252465

    Validate with FDA (Live)

    Device Name
    Any-Core
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2025-12-05

    (121 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K012307
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Repair material for provisionals
    • Cement for pins and posts
    • Semipermanent restorative material (e.g., in childrens' teeth)
    Device Description

    Any-Core is a dual-cured composite material intended for use in core build-up procedures and post cementation. The material demonstrates favorable mechanical properties and is formulated for direct intraoral application onto the tooth surface. Polymerization can be achieved by light-curing or self-curing, offering flexibility in clinical use. Any-Core is available in three shades—A3 (tooth-colored), White, and Blue—providing a combination of natural esthetics and visual contrast to aid in material identification during tooth preparation and placement. The product is supplied in a dual-barrel syringe and used with an automix tip, which enables intraoral dispensing without the need for manual mixing, supporting consistent and efficient delivery.

    AI/ML Overview

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