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510(k) Data Aggregation

    K Number
    K251938
    Date Cleared
    2025-10-30

    (128 days)

    Product Code
    Regulation Number
    872.3640
    Panel
    Dental
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GEN5 and GEN5+ implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially or fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

    Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading.

    Short (<9mmL) Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.

    GEN5 and GEN5+ Abutment System: The GEN5 and GEN5+ Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques.

    Device Description

    The GEN5™ and GEN5+ Dental Implant System consists of a root form Endosseous dental implant, Endosseous dental implant abutment, and various other prosthetic/restorative components (medical devices) to plan, implant, and support restorations for edentulous patients.

    GEN5 and GEN5+ Dental Implants are supplied as a two-piece implant assembly for use in a two-stage or single-stage surgical procedures intended for surgical implantation in edentulous or partially edentulous mandibles or maxilla for attachment of complete denture prostheses, or for fixed or removable bridgework or as a free-standing single tooth replacement. The standard GEN5 Implants are for use in a two-stage surgical procedure. The first surgery is for implant placement, and the second surgery is a few weeks prior to start of prosthetic rehabilitation. By the addition of an abutment of any type at time of implant placement, the implant functions as a one-stage, two-piece system.

    The GEN5 Implant and GEN5+ Implant are the exact same dental implant (internal hex implant). The difference between the two is that the GEN5+ Implant includes a pre-attached hex engaging Extender Healing Abutment (accessory restorative component) screw-retained on the GEN5 Implant prior to packaging requiring only a single surgical procedure prior to prosthetic rehabilitation.

    The top (coronal portion) of the GEN5 Implant body is with a 2.0mm straight neck. The depth gauge lines at 1mm, 2mm and 2.5mm (or at 1mm and 2mm on the ≤9mm length) from the top of the implant facilitate the placement level with the crest of the ridge or 1mm above the crest of the ridge for all implants except the 3.7mmD x 7mmL. The lower apical aspect of the Implant is tapered with double-lead progressively deeper buttress threads. Three cutting flutes extend over the tapered portion of the implant's body. The GEN5+ Implants offer the additional flexibility of a 2mm extender collar that can serve as the trans-mucosal collar of an abutment or can be removed for abutment connection directly to the top of the implant for vertical flexibility.

    The GEN5 and GEN5+ dental implant body is available in five diameter sizes (3.7mm, 4.2mm, 4.7mm, 5.2mm, and 5.7mm) with two platform diameters (3.5mm or 4.5mm), and five lengths (7mm, 9mm, 11mm, 12.5mm, and 14mm). GEN5 and GEN5+ Implants have 2.0mmL of their coronal surface anodized with either a gold (3.5mmD) or a rose gold (4.5mmD) color for aesthetic purposes to help identify the two platform diameters while the remainder of the Implant has gone through a surface treatment (blasting) to create a microtextured surface roughness. These Implants (and the devices included in the packaging) are sold sterile. The GEN5 and GEN5+ Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

    The GEN5 and GEN5+ have an internal hex for abutment connection, which is designed to receive multiple abutment variations expanding its restorative options and allowing for the implant to be used for support of attachment-retained overdentures and cement-retained or screw-retained prostheses.

    The GEN5 Implants are provided with an Internal Hex Carrier while the GEN5+ Implants (a GEN5 Implant pre-fitted with an Extender Healing Abutment) are packaged with an Extender Carrier and an Extender Carrier Fixation Screw.

    The devices are sold in gamma irradiated sterile packaging which consists of an outer vial and an inner vial which is sealed with a threaded cap.

    The Extender Carriers and Extender Carrier Fixation Screws are all manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).

    The various devices included in the GEN5 and GEN5+ Dental Implant System (such as Endosseous dental implant abutments and various other prosthetic/restorative components) used to plan, implant, and support restorations for fully and partially edentulous patients are offered in compatible platform dimensions to enable a complete dental restoration.

    The prosthetic and restorative components (Straight Contoured, Angled-Contoured, ASC, Multi-Unit Abutments, Titanium Multi-Unit Abutment Copings, Titanium Temporary, Healing, Extenders, Cover Screws, Transfers, and Analogs) are all manufactured from titanium alloy (Ti-6Al-4V ELI) and anodized.

    The prosthetic components (PEEK Temporary Abutments) are all manufactured from polyetheretherketone (PEEK).

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