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510(k) Data Aggregation

    K Number
    K012055
    Device Name
    3.25MM SPLINE TWIST IMPLANT
    Manufacturer
    SULZER DENTAL, INC.
    Date Cleared
    2001-09-06

    (66 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K944327,K946311,K962106
    Why did this record match?
    Device Name :

    3.25MM SPLINE TWIST IMPLANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sulzer Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. The 3.15mm implant is recommended for use in the maxillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.

    Device Description

    Spline Twist implants are available with a roughened surface or a selectively Spince Twise Internally in a 3.15mm diameter and lengths of 10, 11.5, 13, 15, and 18mm. All implants have a Spline anti-rotational feature and are fabricated from titanium alloy. The implants are all provided sterile.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. This document is a 510(k) summary for a dental implant, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance study results against specific acceptance criteria.

    Therefore, I cannot fulfill your request with the given input.

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