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510(k) Data Aggregation

    K Number
    K252727

    Validate with FDA (Live)

    Device Name
    Neodent InLab Validated Workflow
    Manufacturer
    JJGC Indústria e Comércio de Materiais Dentários S.A.
    Date Cleared
    2026-01-07

    (132 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K200100,K193352,K233252,K182620,K242686
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K200100, K193352, K233252, K182620

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

    The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

    The digitally designed personalized copings to be used with the Direct Connection Screw to Multi-Unit Abutment are to be:

    • Sent to Straumann for manufacture at a validated milling center, or
    • Manufactured following the Neodent InLab Validated Workflow.

    The Neodent InLab Validated Workflow is indicated for the design and fabrication of screw-retained multi-unit restorations for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components: scan files from intra-oral scanners, CAD software, CAM software, milling machines and associated tooling and accessories.

    Device Description

    The purpose of this premarket notification is to obtain market clearance to expand the options for fabrication of digitally designed personalized copings for use with the Neodent Direct Screw to multiunit abutment (MUA) from a "validated milling center" (cleared in K242686), to include a digital dentistry workflow.

    The Neodent InLab Validated Workflow is integrated by multiple components of digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, milling machines and associated tooling and accessories. This new workflow employs optical impression files that document the topographical characteristics of teeth and traditional dental impressions, which are transferred to the CAD software (CARES® Visual, 3Shape or Exocad) and allows the design of the desired restorations, according to the Direct Screw to MUA dimensions. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration by the indicated milling equipments (Roland and Zirkonzahn).

    AI/ML Overview

    N/A

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