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510(k) Data Aggregation

    K Number
    K252582

    Validate with FDA (Live)

    Date Cleared
    2025-11-18

    (95 days)

    Product Code
    Regulation Number
    872.3630
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

    Compatible Implant Systems: Camlog® CONELOG®, Dentium® NR Line

    Compatible Implant Fixtures:
    Camlog® CONELOG®: 3.3 mm/3.3 mm, 3.8 mm/3.8 mm, 4.3 mm/4.3 mm, 5.0 mm/5.0 mm
    Dentium® NR Line: 3.1 mm/3.2 mm, 3.6 mm

    Device Description

    Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Camlog® CONELOG® and Dentium® NR Line Implant Systems. The products are made from titanium alloy Ti-6Al-4V ELI, which meets ASTM F136-13(2021), Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. The zirconium coping intended for use with the Inclusive® Titanium Abutments 4.5mmH and 6mmH devices are made from zirconium oxide ceramic, conforming to ISO 13356 Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Inclusive® Titanium Abutments 4.5mmH and 6mmH devices are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

    Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136-13(2021) and used in conjunction with the Camlog® CONELOG® and Dentium® NR Line multi-unit abutments. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multi-unit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

    The design parameters for the Titanium Abutment Blanks are:

    • the minimum wall thickness is no less than 0.5 mm.
    • the gingival margin diameter is no less than 0.5 mm wider than implant.
    • maximum angle correction is no greater than 30°. *
    • minimum margin height is no less than 0.5 mm.
    • maximum gingival height is no greater than 6 mm, and
    • minimum post height above the gingival collar is no less than 4.0 mm.

    *Angulation up to 30° for Titanium Abutment Blanks only allowed for compatible implant bodies of Camlog® CONELOG® Ø3.3mm Implants and Dentium® NR Line Ø3.1mm Implants for anterior use in the mouth under single-unit loading.

    Inclusive® Titanium Abutments Blanks compatible with Camlog® CONELOG® Ø3.8mm, Ø4.3mm, and Ø5.0mm Implants are not to be used as angled abutments in the posterior region.

    The design parameters for the zirconia coping for the Titanium Abutment 4.5mmH and 6mmH are:

    • the minimum wall thickness is no less than 0.5mm.
    • the gingival margin diameter is no less than 0.5 mm wider than implant.
    • no angulation correction, straight (0°) only.
    • minimum margin height is no less than 0.5 mm.
    • maximum gingival height is no greater than 6 mm, and
    • minimum post height above the gingival collar is no less than 4.0 mm.
    AI/ML Overview

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