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BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed abutments for use with Conical Ti Base abutments are to be sent to a BioHorizons validated milling center for manufacture or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The BioHorizons Conical Ti Base abutments are prosthetic components and are intended for the restoration of BioHorizons dental implants within the specific indications of each implant system. All Conical Ti Base abutments are two-piece titanium-base type abutments with a pre-manufactured titanium base component cemented to a zirconia superstructure to create the final finished dental abutment. All the titanium bases are manufactured from Ti-6Al-4V titanium alloy per ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications and are for single patient use. The prosthetics are provided non-sterile as indicated on the label. The subject devices are permanent or long-term, tissue/bone implant devices intended for more than 30 days of patient contact. BioHorizons dental prosthetics are invasive and / or surgically invasive devices placed in healed or compromised oral sites in direct contact with bone and soft tissue. The Conical Ti-Base abutments are provided in engaging and non-engaging designs and are designed for single-unit or multi-unit restoration with a CAD/CAM zirconia superstructure attached to the abutment. The titanium base components are available for narrow and regular platforms and with gingival heights of 0.8 mm and 2.0 mm. The titanium base component post has been manufactured with matte finish creating a roughened surface to accommodate cementing. All patient-specific custom abutment fabrication for Conical Ti Base abutments are by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Conical Ti Base abutments are made at a BioHorizons validated milling center under FDA quality system regulations, as cleared in K240187, or according to a digital dentistry workflow (subject of this submission described in the section below). As cleared in K240187, zirconia material, sagemax NexxZr® zirconia (K130991) is used to fabricate the patient-specific zirconia superstructure or direct crown. The cement for bonding of superstructures or crowns is a dual cure cement, 3M™ RelyX™ Unicem 2 Automix (K022476). These cleared materials are identical to the proposed digital dentistry workflow. The pre-manufactured titanium base component are not to be modified and are only intended to permit a customized zirconia restoration. The design and fabrication of the zirconia superstructure will be conducted using a digital dentistry workflow requiring the use of the following equipment: - **Scanner:** 3Shape Trios 5 intra-oral scanner. - **Design Software:** 3Shape Abutment Designer Software, K151455. - **Zirconia Material:** sagemax® NexxZr zirconia, K130991. - **CAM software:** hyperDENT® Classic - **Milling machine:** imes-icore® CORiTEC 150i Pro milling machine - **Cement:** 3M™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement, K022476. The designed superstructure is attached to the titanium base component by the use of an FDA-cleared cement, 3M™ RelyX™Unicem 2 Automix Self-Adhesive Resin Cement, K022476. The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient. The final abutment is equivalent to the final abutment cleared in K240187.

BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants. BioHorizons Tapered Short Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional. BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system, Tapered Pro Conical Implant System, from BioHorizons Implant Systems Inc. The Tapered Pro Conical Implant System includes a range of ental implants and prosthetic components, BioHorizons Tapered Pro Conical implants feature a tapered screw-shaped design with a reverse buttress thread. Cutting flutes are incorporated into the thread to be self-tapping when placed into the prepared surgical site. The outer surface of the implant has been roughened with resorbable blast texturing (RBT) using a hydroxyapatite blast media. Internally, the implant features a deep conical prosthetic connection between implants and abutments with six anti-rotation cams at the base of the connection, intended to interface with the three cams of the prosthetic components. It is available with or without Laser-Lok treatment applied to the collar of the implant. Tapered Pro Conical Implants are available in a range of implant diameters and lengths with two prosthetic platform (implant/abutment connection) sizes, as shown below. Internal surfaces of the Tapered Pro Conical Regular platform implants are anodized yellow to distinguish them from Narrow platform implants. Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations. The Conical Ti-Base abutments are a two-piece abutment composed of a pre-manufactured Ti Base component and a CAD/CAM patient-matched mesostructure (superstructure) composed of sagemax® NexxZr zirconia (K130991).