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510(k) Data Aggregation

    K Number
    K231455
    Device Name
    Implant-One System
    Manufacturer
    Implant Logistics, Inc.
    Date Cleared
    2023-08-15

    (89 days)

    Product Code
    NHA,PNP
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K212394,K102822,K173701,K180899
    Why did this record match?
    Reference Devices :

    K212394, K102822, K173701

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

    Implant-One™ System Abutments are intended for use as an aid in prosthetic rehabilitation in the mandible or maxilla for support of single-unit or multi-unit restorations.

    The Implant-One Ti-Base Abutment consists of the titanium base and a mesostructure component, making up a two-piece abutment, and will be attached to the implant using an abutment screw. The mesostructure for use with the Implant-One Ti-Base is intended only to be designed and manufactured according to digital dentistry workflow that integrates scan files from lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

    Device Description

    The subject devices comprise abutments designed for the 300, 400, and 500 Series of the Implant-One" system. All subject device abutments incorporate a Morse taper at the implant/abutment interface, have a hexagonal male end for alignment purposes and are screw retained. The series is grouped according to the implant/abutment interface size and each series is color coded for ease of identification. The subject devices are Titanium Base Abutments.

    The Implant-One™ Titanium Base Abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. The Implant-One" Titanium Base Abutments consist of two major components. Specifically, the titanium base and the mesostructured component make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling.

    The standard Ti Base Abutments are offered in cuff heights of 0.5mm, 1.5mm and have a Ø4.0mm profile for the 300 series and a Ø4.5mm profile for the 400 & 500 series.

    The following components are intended to be used for scanning, designing and manufacturing of ceramic mesostructures for the Implant-One™ Titanium Base Abutment:

    • Lab scanner: Medit/Identica T500 3D Scanner (Medit Corp) ●
    • CAD software (PNP): 3Shape Abutment Designer & Abutment Design (3Shape A/S -● K151455 & K200100) and exocad AbutmentCAD (exocad GmbH - K193352)
    • Ceramic material: Katana™ Zirconia (Kuraray Noritake Dental, Inc. K143439) ●
    • . Milling machine: Ceramill Motion 2 (Amann-Girrbach AG)
    • Milling software: Ceramill Match 2 CAM Software (Amann Girrbach AG)
    • Cement: RelyX™ Luting Plus Automix Cement (3M ESPE Dental Products K11185) ●
    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for a dental implant abutment system (Implant-One™ System). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting an AI/ML-based device performance study.

    Therefore, the document does not contain the information requested regarding acceptance criteria and performance data for an AI/ML device, as it describes a traditional medical device submission.

    Specifically, the following points from your request cannot be addressed based on the provided text:

    • A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria for an AI/ML system or statistical performance metrics. Instead, it describes mechanical testing (ISO 14801) and sterilization validation (ISO 17665-1 and ISO 17665-2) for a physical medical device.
    • Sample size used for the test set and the data provenance: There is no "test set" in the context of AI/ML evaluation. The performance data refers to mechanical and sterilization tests, not data for an algorithm.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is irrelevant in this context, as there is no AI/ML algorithm being evaluated.
    • Adjudication method: Not applicable due to the absence of an AI/ML performance study.
    • If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states "No clinical data were used in support of this submission," meaning no MRMC study was performed.
    • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
    • The type of ground truth used: Not applicable.
    • The sample size for the training set: Not applicable, as this is not an AI/ML device.
    • How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

    The document primarily focuses on demonstrating that the Implant-One™ System is substantially equivalent to a legally marketed predicate device (NobelActive™ Universal Base Abutments) by comparing their indications for use, technological characteristics, materials, dimensions, and sterilization methods. It mentions "Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations," which refers to CAD/CAM software used in the manufacturing process, not an AI/ML diagnostic or prognostic algorithm.

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