LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K193234
    Device Name
    NUVO IF Implant System
    Manufacturer
    JJGC Industria e Comercio de Materiais Dentarios S.A.
    Date Cleared
    2020-06-18

    (206 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K150203,K150367,K153624,K163194,K173902,K190040,K190718,K191191,K192229,K101945
    Why did this record match?
    Device Name :

    NUVO IF Implant System

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

    Indications for Use for NUVO IF Implants and conventional abutments:

    The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or twostage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

    The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.

    The Attachment Equator and Attachment Removable Prosthesis are indicated for the attachment of full or partial dentures to NUVO implants.

    Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:

    Titanium Base Abutment is a titanium base placed onto dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement or screw-retained single or multi-unit restorations or screw-retained single restorations.

    All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

    The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.

    Indications for Use for CARES® Abutment IF:

    The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for cementretained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.

    Device Description

    The NUVO IF Implant System consists of implants, cover screws, and abutments.

    Implants: Intended for single use, provided sterile via gamma irradiation, manufactured of commercially pure titanium (Grade 4), bone level design, apically tapered thread-form with apical cutting flutes in various diameters and lengths, and provided with an internal hexagonal implant-to-abutment interface.

    Cover Screws: Intended for single use, used to protect the internal geometry of the implants during healing, placed out of occlusion, provided sterile via gamma irradiation or ethylene oxide gas, manufactured of titanium alloy (Ti6Al4V-ELI), and provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants.

    Abutments: Intended for single use, provided sterile via ethylene oxide gas or non-sterile, manufactured of titanium alloy (Ti6Al4V-ELI) or a combination of POM polymer and cobalt-chromium alloy, conical format available in different diameters, height of cementable area and gingival height, screw-retained to the implant, provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants, provided with coronal geometries in rotational (non-indexed) and anti-rotational (indexed) versions, and Titanium Base abutments are two-piece abutments composed of a titanium base and a patient-specific CAD/CAM top-half.

    AI/ML Overview

    This looks like a 510(k) summary for a dental implant system (NUVO IF Implant System), not a study describing acceptance criteria and performance data for an AI/ML medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI device.

    The document discusses:

    • Trade/Device Name: NUVO IF Implant System
    • Regulation Number/Name: 21 CFR 872.3640, Endosseous Dental Implant
    • Regulatory Class: Class II
    • Product Code: DZE, NHA
    • Indications for Use: Surgical placement in maxilla or mandible for prosthetic device support, including immediate loading, temporary support, and attachment of dentures.
    • Device Description: Details on implants (material, design, size, sterilization), cover screws (material, use, sterilization), and various abutment types (materials, design, sterilization, use).
    • Predicate Devices: Several predicate devices are listed and compared for substantial equivalence.
    • Performance Data: This section details non-AI/ML performance testing, including:
      • Dynamic fatigue testing per ISO 14801.
      • Sterilization validation (gamma irradiation per ISO 11137-1/2, ethylene oxide per ISO 11135, moist heat per ISO 17665-2).
      • Ethylene oxide residuals testing per ISO 10993-7.
      • Biological Safety Assessment per ISO 10993-1 (cytotoxicity per ISO 10993-5, chemical characterization per ISO 10993-18).
      • Package transport integrity per ISTA 2A.
      • Product and package stability per ASTM F1980.
      • Product endotoxin testing (LAL) per ANSI/AAMI ST72.

    There is no mention of an AI/human-in-the-loop study, ground truth establishment, sample sizes for training/test sets for AI, or expert adjudication.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1