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510(k) Data Aggregation

    K Number
    K220878
    Device Name
    Straumann TLX Variobase C
    Manufacturer
    Institut Straumann AG
    Date Cleared
    2022-06-16

    (83 days)

    Product Code
    NHA,PNP
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K181520,K151324,K200586,K142890,K190662,K192742
    Why did this record match?
    Device Name :

    Straumann TLX Variobase C

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

    The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

    All digitally designed copings and/or crowns for use with the Straumann® TLX Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

    Device Description

    The Straumann® TLX Variobase® C abutments are two-piece abutments composed of the following components:

    • . Straumann® TLX Variobase® C (Ti-base)
    • Prosthetic Restoration (patient specific coping or crown) .
    • . Basal Screw

    The Straumann® TLX Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platform: NT (Narrow TorcFit), RT (Regular TorcFit), and WT (Wide TorcFit). The Straumann® TLX Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half material that is compatible with the Straumann® TLX Variobase® C abutments is IPS e.max CAD.

    AI/ML Overview

    The provided document is a 510(k) Summary for a dental device, the "Straumann® TLX Variobase® C". This document describes the device, its intended use, and how it compares to predicate devices. It does not describe a study involving an AI/ML algorithm or its performance characteristics.

    Therefore, I cannot provide the information requested in your prompt because the document does not contain details about:

    • Acceptance criteria for an AI/ML device.
    • A study proving an AI/ML device meets acceptance criteria.
    • Sample sizes for test or training sets for an AI/ML model.
    • Ground truth establishment methods for AI/ML data.
    • Expert consensus or adjudication for AI/ML performance evaluation.
    • MRMC studies for AI/ML or human-in-the-loop performance.
    • Standalone AI algorithm performance.

    The "Performance Testing" section (Page 10, section {10}) refers to mechanical and software validation testing for a dental abutment, not an AI/ML algorithm. Specifically, it mentions:

    • Dynamic fatigue and static strength tests (mechanical performance).
    • Biocompatibility (material safety).
    • Sterilization process validation.
    • Software verification and validation for the abutment design library to ensure it operates within specified design limitations.

    The software validation mentioned is to ensure the design software for the dental abutment (Sirona Dental CAD/CAM System) correctly applies design restrictions, not to evaluate an AI's diagnostic or predictive performance.

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