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510(k) Data Aggregation

    K Number
    K251515

    Validate with FDA (Live)

    Device Name
    Solidex® Ti-Links and Screws
    Manufacturer
    CreoDent Hudson Valley
    Date Cleared
    2026-02-10

    (270 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K083550,K121131,K122231,K130991,K183537,K151455,K180703,K240982
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Solidex® Ti-Links and Screws is intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed custom abutments for use with Solidex® Ti-Links is to be sent to a CREODENT HUDSON VALLEY validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.

    Device Description

    Solidex® Ti-Links & Screws consists of a two-piece abutment, where the titanium base will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a Solidex® Screw for fixation to the implant body. Solidex® Ti-Link are made of titanium alloy conforming to ASTM F136 standard specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters. Solidex® Screw is composed of titanium alloy per ASTM F136.

    Solidex® Ti-Links & Screws is designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. There are two-piece abutments for which the second part (or top half) is the zirconia superstructure. They also may be used for support of a crown directly on the Ti-Link. CAD/CAM zirconia superstructure fabrication for Ti-Link is by prescription on the order of the clinician.

    Solidex® Ti-Links & Screws all zirconia superstructures for use with the subject device Ti-Link will be manufactured using a digital dentistry workflow, either at a Validated Milling Center (VMC) or at the Point of Care (POC), by using scan files from intra-oral and lab (desktop) scanners, CAD/CAM software, ceramic material, and associated tooling and accessories. The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD/CAM software, ceramic material, and associated tooling and accessories. The digital workflow includes the following products:

    • Ceramic material: Sagemax NexxZr T (K130991)

    • Cement: Panavia SA cement Universal (K183537)

    • Desktop scanner: 3Shape E series Lab Scanner (510(k) exempt under 21 CFR 872.3661)

    • Design software: 3Shape Abutment Designer Software (K151455)

    • Milling machine: PrograMill PM7 (510(k) exempt under 21 CFR 872.3661)

    • Milling software: PrograMill CAM (510(k) exempt under 21 CFR 872.3661)

    • Digital Library / Templates (3 Shape): The Solidex® Ti-Link CAD/CAM System shall only be used with the official "Solidex® Ti-Link Digital Library" and templates identified. The library is imported into the 3Shape software, and the design restriction parameters (minimum wall thickness, post height, maximum gingival height, etc.) are automatically applied. The official "Solidex® Ti-Link Digital Library" can be obtained from CREODENT HUDSON VALLEY by contacting support email (inquiry@creodental.com) or from CREODENT HUDSON VALLEY web-site.

    When imported into the 3Shape software, the design restriction parameters (minimum wall thickness, post height, maximum gingival height, etc.) and built-in protection features ("stops" and restriction shells) are automatically applied.

    The design parameters for the CAD/CAM zirconia superstructure to be used Solidex® Ti-Links & Screws:

    • Minimum wall thickness: 0.5 mm
    • Minimum abutment post height: 6.0 mm
      (Note)
      : The abutment post height is the dimension above the gingival height.
      : Feature maximum abutment post height are based on patient anatomy and clinician discretion.
    • Minimum gingival height: 0.5 mm
    • Maximum gingival height: 6.0 mm
    • Minimum Angulation: 0°
    • Maximum Angulation: 20°

    The zirconia superstructure must be cemented to the Solidex® Ti-Links using Panavia SA cement Universal in a dental laboratory. Solidex® Ti-Links & Screws is provided non-sterile therefore must be sterilized after the cementation of the zirconia superstructure on Solidex® Ti-Links. Solidex® Screws are designed to attach the abutment to the implant.

    AI/ML Overview

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