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510(k) Data Aggregation

    K Number
    K253167

    Validate with FDA (Live)

    Device Name
    Any-Paste
    Manufacturer
    Date Cleared
    2026-01-12

    (108 days)

    Product Code
    Regulation Number
    872.3820
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Any-Paste is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery
    • Any-Paste can be used on its own and for vital pulpotomy indeciduous teeth
    • Any-Paste is intended for use by qualified healthcare personnel trained in its use
    Device Description

    Any-Paste is an effective intracanal medicament and temporary root canal filling material for pulp capping and treatment of infected root canals. The material, primarily composed of barium sulfate and calcium hydroxide and radiopacity. As a water-soluble formulation, it can be easily cleaned and removed. Provided in a pre-mixed paste form in a convenient syringe, the material remains stable within the syringe without separation or hardening.

    AI/ML Overview

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