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The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function. INTERNA 3.0 UnicCa® implants with a diameter of 3.3 mm are only intended to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load. INTERNA 3.0 UnicCa® implants with a diameter of 3.0 mm are only intended for replacement of maxillary lateral incisors and mandibular incisors, and are only intended for delayed loading. INTERNA 3.0 UnicCa® implants with a diameter of 2.5 mm are only indicated for missing mandibular central and lateral incisors, and are only intended for delayed loading. All digitally designed zirconia components for use with Aesthetic Post Abutments are to be sent to a BTI validated milling center for manufacture.

The purpose of this submission is to add components to the B.T.I. Biotechnology Institute, S.L. product line of endosseous dental implants, abutments, and prosthetic components. Specifically this submission seeks marketing clearance for dental implants with body diameters of 2.5 mm, 3.0 mm, various compatible conventional abutments, and two-piece abutments to be used with a zirconia superstructure fabricated using CAD-CAM technology. The subject device Interna 3.0 implants have an internal hexolobular connection and a platform diameter of 3.0 mm. The implants are provided in body diameters of 2.5 mm, 3.0 mm. Each body diameter is provided in overall lengths of 8.5 mm, 10 mm, 11.5 mm. The subject implants are manufactured from unalloyed titanium (conforming to ASTM F67 and ISO 5832-2), and the endosseous surface has the UniCa" surface treatment that improves the hydrophilicity of the implant. The subject device abutments are provided in various designs including Healing Abutments. Healing Screws, Temporary Titanium Abutments, Definitive Titanium Abutments, Square Abutments (Ti-Bases), Transeptihelial Abutments (Single-unit and Multi-unit, with corresponding screws), and Aesthetic Interfaces for Transepthelial Abutments. The Temporary Titanium Abutments and Definitive Titanium Abutments are provided straight (00) only and are not to be customized to create an angled abutment or to correct for angulation. The subject Square Abutments are two-piece abutments consisting of titanium bases combined with ceramic superstructures, to be attached directly to the Interna 3.0 implants to support single-unit or multi-unit restorations. The Square Abutments are provided in gingival heights ranging from 0.5 mm to 3 mm, with a titanium base platform diameter ranging from 3.76 mm. The titanium base post height (length above the gingival height) either is 3.5 mm, or in versions with an angled screw access channel, 6.5 mm with a cut-down post height of 2.1 mm, 3 mm, or 3.5 mm. The post of all titanium base versions includes an anti-rotation design to prevent rotation of the superstructure or hybrid crown. The abutments are used with cemented and screw-retained restorations. The fabrication of the top-half of the abutment by conventional workflow was cleared in K211952, and a workflow using CAD-CAM technology to design and fabricate a superstructure or hybrid crown-abutment was cleared in K231827. The ceramic material to be used will be zirconia conforming to ISO 13356. All fabrication of the patient specific superstructures for use with the Square Abutments will be done at a BTI validated milling center. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436. The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Square Abutments are: minimum wall thickness – 0.4 mm minimum post height for single-unit restoration (post height is the length above the gingival height) – 4.0 mm maximum gingival height - 6 mm minimum gingival height - 0.0 mm in the superstructure (all Square Abutments have a minimum gingival height of 0.5 mm) maximum angle - 0°, straight only. Transepithelial Abutments are for supporting single-unit or multi-unit, temporary or definitive, restorations on the Interna 3.0 implants. Transepthelial Abutments are provided to fit implants with a body diameter of 2.5 mm, and to fit body diameters of either 3.0 mm. Transepithelial Abutments are provided in a variety of gingival heights ranging from 0.5 mm. Transepithelial Abutments are used with previously cleared BTI retention screws, temporary cylinders, aesthetic interfaces, and the subject device Interfaces for Transepithelial Abutments. The subject Aesthetic Interfaces for Transepithelial Abutments are two-piece abutments on titanium bases combined with ceramic superstructures, used to support single or multi-unit definitive prosthetic restorations. Aesthetic Interfaces for Transepithelial Abutments are provided in gingival heights of 0.5 mm to 1.05 mm, titanium base diameters ranging from 3.5 mm, and titanium base post heights (length above the gingival height) ranging from 5.45 mm to 6.5 mm. Aesthetic Interfaces for Transepithelials are provided in two configurations, Straight and Expanded configurations have a larger titanium base platform diameter than the Straight configurations with the same platform diameter. The titanium base platform diameters range from 3.5 mm to 6.5 mm and all designs include anti-rotation indexes to prevent rotation of the superstructure or hybrid crown. The fabrication of the top-half of the abutment by conventional workflow was cleared in K211952 and a workflow using CAD-CAM technology to design and fabricate a superstructure or hybrid crown-abutment was cleared in K231827. The ceramic material to be used will be zirconia conforming to ISO 13356. All fabrication of the patient specific superstructures will be done at BTI validated milling center. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436. The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelial Abutments are: minimum wall thickness - 0.4 mm minimum post height for single-unit restoration (post height is the length above the gingival height) – 4 mm maximum gingival height - 6 mm minimum gingival height - 0.0 mm in the superstructure (all Aesthetic Interfaces have a minimum gingival height of 0.5 mm) maximum angle - 0°, straight only. All subject device abutments are manufactured from unalloyed titanium conforming to ASTM F67 and ISO 5832-2, and zirconia confirming to ISO 13356. Selected abutments are provided with a Titanium Nitride (TiN) coating to enhance the aesthetic appearance of the device. Subject device abutments used with screws previously cleared in K211952 and K053355. The screws that are part of the Transepithelial Abutment assemblies are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3. The screws have a diamond-like carbon (DLC) coating that is identical to the DLC coating on screws cleared in K211952. Subject device components provided sterile by gamma irradiation include the Interna 3.0 Implants, Healing Abutments, Healing Screws, and Transepithelial Abutments. Components provided non-sterile for end-user moist heat sterilization include the Temporary Titanium Abutments, Definitive Titanium Abutments, Square Abutments, Aesthetic Interfaces for Transepithelial Abutments, and retention screws.

The BTI Interna Prosthetic Components are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System. All digitally designed zirconia components for use with Aesthetic post abutments are to be sent to a BTI validated milling center for manufacture.

The purpose of this 510(k) is to expand the BTI product offering and include a variety of abutments compatible with the already cleared BTI Dental Implants. Subject device abutments include 15° Angled abutments, Transepithelial abutments, Temporary titanium abutments, Healing caps, Aesthetic post abutments and Screws. Aesthetic post abutments include Square abutments and Aesthetic interfaces for Transepithelials, as the bottom part of a two-piece abutment. A zirconia superstructure fabricated through CAD-CAM technology is the upper part of the two-piece abutment. The subject 15º Angled Titanium abutments are designed to a BTI Interna Narrow implant, to hold single and multiple cement-retained restorations. The compatible BTI implants have been previously cleared in K211952. The abutments are offered with a 15º angulation and gingival heights of 3.0, 4.0, and 5.0 mm. They are manufactured in commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance. The subject Temporary abutments are designed for single-unit screw-retained restorations on Transepithelial abutments are offered in prosthetic diameters of 3.5, 5.0 and 5.5 mm, with no angulation. They are manufactured from commercially pure titanium. The subject Transepithelial abutments are designed for single-unit and multi-unit screw-retained restorations on previously cleared BTI implants. The compatible BTI implants have been previously cleared in K211952, K202825, K173257, and K151391. They are available in an engaging and a non-enqaging connection. They are offered in a prosthetic platform diameter of 3.5, 5.0 and 5.5 mm, and gingival heights ranging from 0.5 to 5.0 mm, with 0°, 17° and 30° angulation. They are manufactured from commercially pure titanium, with a TiN coating on abutment surface. The retention screw is provided with the abutment and is manufactured from titanium alloy with a DLC coating. The subject Healing caps are designed to be connected to a Transepithelial abutment implant during the healing period, between Transepithelial placement and final dental restoration placement. These abutments are provided in prosthetic diameters of 3.5 and 5.0 mm. They are manufactured from commercially pure titanium and anodized. The subject Aesthetic interfaces are two-piece abutments composed of a bottom half titanium component, and a patient-specific designed CAD-CAM zirconia superstructure as a top half component. The Aesthetic interfaces are to be attached to a Transepithelial abutment to hold single or multi-unit restorations. They are fabricated from commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance. The design parameters for this top-half abutment fabrication are as follows: - Minimum wall thickness: 0.4 mm - - Minimum post height for single-unit restorations: 4.0 mm - - Minimum gingival height: 0 mm in the zirconia superstructure - - -Maximum gingival height: 6.0 mm - -Maximum angulation: 0° The subject Square abutments are two-piece abutments, composed of a bottom half titanium component, and a patient-specific designed CAD-CAM zirconia superstructure as a top half component. The Square abutments are to be attached to a BTI implant to hold single or multi-unit restorations. The compatible BTI implants have been previously cleared in K211952, K202825, K173257, and K151391. They are fabricated from commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance. The subject Square abutments are straight abutments (0%, and are provided in a variety of gingival heights ranging from 0.5 mm to 3.0 mm. The design parameters for this top-half abutment fabrication are as follows: - Minimum wall thickness: 0.4 mm - - -Minimum post height for single-unit restorations: 4.0 mm - Minimum qingival height: 0 mm in the zirconia superstructure - - Maximum gingival height: 6.0 mm - The zirconia superstructures for use with the subject Square abutments and Aesthetic Interfaces will be made at a BTI validated milling center and the material will conform to ISO 13356. The bonding cement recommended for the zirconia superstructure is Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436. The subject Screws are designed to attach Square abutments and Aesthetic Interfaces to the compatible BTI dental implant or Transepithelial abutment, respectively. The Screws are manufactured from titanium allov, with a DLC coating on screw thread. One subject Screw is also anodized for ease identification.

The BTI Interna Dental Implant System UnicCa® - Prosthetic Components are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System implants. All digitally designed zirconia components for use with Square Aesthetic Abutments and Aesthetic Interfaces for Transepithelials are to be sent to a BTI validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for the subject device abutments, Square Aesthetic Abutments and Aesthetic Interfaces for Transepithelials, as part of a two-piece abutment with a zirconia superstructure fabricated using CAD-CAM technology. The subject Square Aesthetic abutments are stock manufactured abutments, to be attached directly to BTI dental implants with the Interna implant connection (Narrow, Universal Plus and Wide platforms), to hold single or multiple restorations. The Square Aesthetic abutments are compatible with BTI implants previously cleared in K211952, K202825, K173257, and K151391. The subject Square Aesthetic abutments are provided in a variety of gingival heights ranging from 0.5 mm, with a prosthetic platform diameter ranging from 4.0 mm to 5.9 mm, and a prosthetic post height of 3.5 mm. All versions include anti-rotation indexes to prevent crown or bridge rotation. Engaging and non-engaging designs are available for single and multiple restorations, respectively. The abutments are used with cemented and screw-retained restorations. The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Square Aesthetic Abutments are: minimum wall thickness - 0.45 mm minimum post height for single-unit restoration - 4.2 mm maximum gingival height - 6.0 mm minimum gingival height - 0 mm in the zirconia superstructure maximum angle - 0°, straight only. The subject Aesthetic Interfaces for Transepithelials are stock manufactured abutments, used to support single or multi-unit definitive prosthetic restorations over BTI Transepthelial Abutments (Unit and Multi-im, respectively). The compatible Transepithelial Abutments were previously cleared in K213106 and the Transepithelial Abutments are compatible with the BTI Interna connection implants (Narrow, Universal, Universal Plus and Wide platforms), previously cleared in K211952, K202825, K173257, and K151391. The previously cleared Transepithelial Abutments have a minimum gingival height of 1.0 mm and the Aesthetic Interfaces for Transepithelials have a minimum gingival height of 0.3 mm; when used together (as required) the minimum gingival height is 1.3 mm. The Aesthetic Interfaces for Transepithelials are provided in a range of prosthetic diameters from 3.5 mm, with a range of post heights from 3.5 mm. The Aesthetic Interfaces for Transepithelials are provided in two configurations, Straight and Expanded configurations have a larger prosthetic platform diameter than the Straight configurations with the same platform diameter. Overall, the prosthetic platform diameters range from 3.5 mm to 6.5 mm. The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelials vary for the minimum wall thickness and prostheight depending on the design of the Aesthetic Interface and the corresponding Transepithelial Abutments. The overall design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelials are: minimum wall thickness - 0.4 mm minimum post height for single-unit restoration - 4 mm maximum gingival height - 6.0 mm minimum gingival height - 0 mm in the zirconia superstructure maximum angle - 0°, straight only. All zirconia superstructures for use with the subject device will be made at a B.T.I. Biotechnology Institute, S.L. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar AG, cleared in K130436). All subject device components are manufactured from unalloyed titanium conforming to ASTM F67 and ISO 5832-2 and are provided with a Titanium Nitride (TiN) coating to enhance of the device. All subject device components are used with abutment and prosthetic screws previously cleared in K213106, and K053355.

The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function. In the case of 5.5 - 6.5mm long UnicCa® implants: These implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations. In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

The BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided with two types of connections; external (i.e., Externa®) and internal (i.e., Interna®), in a variety of platforms and range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant. The purpose of this 510(k) is to allow B.T.I. Biotechnology Institute, S.L. to expand the product offering for the Universal and Universal Plus Interna® implant platforms. Specifically, the currently cleared Universal Interna® implants with diameters ranging from 4.0 to 4.25 mm and the 6.0 mm diameter Universal Plus Interna® implants will be provided in shorter lengths of 5.5 and 6.5 mm. The implants subject of this premarket notification, collectively referred to as BTI Extra-Short Dental Implant System UnicCa®, are summarized in Table 5-1.

The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function. In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations. In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

The BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided with two types of connections; external (i.e., Externa®) and internal (i.e., Interna®), in a variety of platforms and range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant. The purpose of this 510(k) is to allow B.T.I. to expand the product offering for the Wide and Universal Plus 5.5 mm and 6.0 mm diameter Interna® implants to extend implant length up to 15 mm.

The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function. In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations . In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant. Comprises two types of connections: Externa® and Interna® with a range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm) for various platforms, we refer to Table 5-1. BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

BTI Dental implants 5.5 - 6.5 mm are intended to be used to restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure. These implants are not indicated for immediate loading. These implants are not indicated to support removable resilient retained restorations or angled abutments.

The BTI Dental Implant 5.5-6.5 is a self tapping, threaded dental implant intended for restoring missing teeth in partially or fully edentulous patients to restore the chewing capacity of patients. It is made of titanium and offers a variety of sizes including diameters: 4.5, 5.0, 5.5, 6.0 and lengths: 5.5, 6.5

BTI Dental Implant Tiny® 3.0 are intended to be used to restore missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients. These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

The BTI Dental Implant Tiny® Ø3.0 is a self tapping, threaded, root- form dental implant intended for restoring missing teeth in partially or fully edentulous patients to restore the chewing capacity of patients. It is made of titanium and offers a variety of sizes including diameter: 3.0mm and lengths: 11.5, 13, 15mm

Endosseous dental implant angled abutments are premanufactured prosthetic components directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation. They can be used in singled and multi-unit restorations where angled correction is required.

BTI Endosseous dental implant angled abutments consist of 15 degree angled abutments. The artificial tooth abutments are designed to fit and function on the internal and external BTI conexion implants. They can be used in singled and multi-unit restorations where angled correction is required. The angled abutments differ from the BTI predicate abutments in that the abutments are angled. The angled abutments provide for more flexibility in the implant placement and restoration process.

Dental burs are intended to drill bone tissue and provisionally soft tissues during, before and after a surgical intervention of dental implants. Endosseous dental implant abutments are intended to model the gingival tissue during the process of healing after the first or second surgery and to be attached to the implant to hold single or multiple teeth restorations.

Dental bur are rotary cutting devices intended to cut hard structures in the mouth, such as teeth or bone. They are also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices. Endosseous dental implant abutments are premanufactured prosthetic component directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation.