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510(k) Data Aggregation

    K Number
    K252450

    Validate with FDA (Live)

    Device Name
    Adhese 2
    Manufacturer
    Ivoclar Vivadent, Inc.
    Date Cleared
    2026-03-05

    (213 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K210804
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    – Missing tooth structure
    – Defective restorations

    Areas of application:

    a. Pure self-curing of Adhese 2 only in combination with VivaPen DC cannulas and DC applicators
    – Adhesive cementation of indirect restorations and endodontic posts using Variolink® Esthetic DC in combination with all etching techniques.
    – Adhesive cementation of indirect restorations and endodontic posts using light- and dual-curing luting composites in combination with the etch & rinse technique.

    b. Light-curing of Adhese 2 at 500 to 1400 mW/cm2 (10 seconds) or at 1800 to 2200 mW/cm2 (5 seconds)
    – Adhesive cementation of indirect restorations with light- and dual-curing luting composites
    – Directly placed reconstructive build-ups and core build-ups made with light-, self- and dual-curing composites
    – Directly placed light-curing composite and compomer restorations
    – Repair of fractured composite and compomer restorations
    – Desensitization of hypersensitive cervical areas
    (Note: Provide additional cooling with an air syringe when applying the product.)
    – Sealing of prepared tooth surfaces before temporary/permanent cementation of indirect restorations

    c. Light-curing of Adhese 2 using Bluephase PowerCure in the 3sCure curing mode
    – Only restorations in the posterior region of permanent dentition
    (Class I and II, including the replacement of individual cusps) when light-cured from the occlusal aspect.

    Device Description

    Adhese® 2 is a dual-curing single-component dental adhesive for enamel and dentin that is compatible with all etching techniques (self-etch, selective-enamel-etch and etch & rinse techniques).

    The areas of application include adhesive cementation of indirect restorations and direct restorative procedures.

    Adhese 2 can either be light-cured for 10 s at a light intensity of 500 to 1,400 mW/cm2 or for 5 s at a light intensity of 1,800 to 2,200 mW/cm2.

    In the restoration of Class I and II cavities, Adhese 2 can be light-cured in only 3 s from the occlusal aspect at a light intensity of 2,700 to 3,300 mW/cm2.

    Adhese 2 is available in the VivaPen®, in bottles or in Free Stand® Single Dose units.

    AI/ML Overview

    N/A

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