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510(k) Data Aggregation

    K Number
    K200100
    Device Name
    Abutment Design
    Manufacturer
    3Shape A/S
    Date Cleared
    2020-10-07

    (265 days)

    Product Code
    PNP
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K151455
    Predicate For
    K221107,K231529,K233252
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Abutment Design is intended as an aid to the restoration in partially or fully edentulous mandibles and maxillae. Abutment Design is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, or hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

    Device Description

    The Abutment Design software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching endosseous dental implant abutments using computer aided design.

    The Abutment Design is restricted to be used with 510(k) cleared abutment systems, and the design output from Abutment Design (the patient specific part of the abutment) must be manufactured according to the instruction of the selected abutment system.

    The Abutment Design software includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, gingival height, angulation, gingival margin diameter, etc.). The design parameters, provided by abutment system manufacturers, for an abutment system are available via a 3Shape server when documentation of the 510(k) clearance of said implant system is presented to 3Shape.

    Abutment Design has no patient contact being a software only device.

    AI/ML Overview

    I am sorry, but the provided text only discusses the comparability of "Abutment Design" software to a predicate device, and includes general statements about nonclinical testing for verification and validation without providing specific acceptance criteria or study details that would allow me to populate the requested table and answer the detailed questions about sample sizes, ground truth, expert qualifications, and specific study designs.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

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