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510(k) Data Aggregation

    K Number
    K061781
    Device Name
    MULTILINK SPRINT
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2006-09-05

    (71 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Multilink Sprint is a self-adhesive, dual curing luting composite for the permanent cementation of direct restorations made of:

    • Metal and metal-ceramic (inlays, onlays, crowns, bridges and posts) .
    • High-strength all ceramic: zirconiumoxide-, Lithiumdisilicate and . Aluminum oxide ceramic (crowns, bridges, and posts)
    • Fiber-enforced composites (posts:) .
    Device Description

    Multilink Sprint is a self-adhesive, dual curing luting composite.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental cement called "Multilink Sprint." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter primarily:

    • Confirms that the device is substantially equivalent to legally marketed predicate devices.
    • Outlines general regulatory requirements the manufacturer must comply with.
    • Lists the "Indications for Use" for the Multilink Sprint, which specify the types of restorations it can permanently cement.

    Therefore, I cannot provide the requested information based on the provided text. The document is regulatory approval, not a scientific study report.

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