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The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: Table 1. | Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] | |--------------------------------|------------------------|----------------------------| | Astra Tech EV 3.0 | Ø3 | Ø3 | | Astra Tech EV 3.6 | Ø3.6 | Ø3.6 | | Astra Tech EV 4.2 | Ø4.2 | Ø3.6 & Ø4.2 | | Astra Tech EV 4.8 | Ø4.8 | Ø4.2 & Ø4.8 | | Astra Tech EV 5.4 | Ø5.4 | Ø5.4 | The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software. CAM software, ceramic material, milling machine and associated tooling and accessories,

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ functions as an interface between a dental implant and a zirconia superstructure. It attaches to the implant using the included prosthetic screw and connects to the zirconia superstructure through cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device. The Elos Accurate® Hybrid Base™ is available for two types: Engaging and Non-Engaging. - The Hybrid Base™ Engaging which is intended for single tooth dental restorations and having an indexing feature. which avoid the Hybrid Base from rotating in the implant. - -The Hybrid Base™ Non-Engaging is intended for multiple tooth dental restorations and has no indexing feature, which allows the Hybrid Base to rotate in the implant. The Elos Accurate® Hybrid Base™ is available with 4 different collar heights and is provided with a 7,5mm chimney which can be cut down to several heights by the user, to minimum 3,5 mm. The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits: | Hybrid Base abutments (zirconia part): | |-----------------------------------------| | Min. wall thickness 0.5 mm | | Gingival height min. 0.5mm or max. 5 mm | | Max. angulation 20°. | | Min. post height* 4 mm | *The post height is defined as the cementable height of the abutment. The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw. The Prosthetic Screw, also made of Titanium Alloy (ASTM F136), provided for the Elos Accurate® Hybrid Base™ is used to secure the final prosthetic restoration to the implant in the patient's mouth. The Prosthetic Screws have a hexalobular driver connection interface. The intended driver to be used with the Elos Accurate® Hexalobular Prosthetic Screws is the Elos Accurate® Prosthetic Screwdriver 18mm, 26mm or 34mm (Ref. No. PS-AH18-1, PS-AH26-1 or PS-AH34-1). These screwdrivers are Class I Exempt devices per FDA product code NDP. The Elos Accurate® Hybrid Base has a gold anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K230317. The subject prosthetic screws are provided anodized identical to reference device K120414. The Elos Accurate® Hybrid Base™ and the Prosthetic screw is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient. The recommended sterilization procedure is full cycle pre-vacuum steam sterilization at a temperature of 132 °C (270°F) for 4 minutes. Dry time: 20 minutes. The Elos Accurate® Hybrid Base™ is sold in 1 pc. packaging and the Elos Accurate® Prosthetic screw is sold in 1 pc. packaging.

Elos Accurate Hybrid Base The Elos Accurate® Hybrid Base The intended for attaching to dental inplants in order to provide basis for dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: Table 1. Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 The zirconia superstructures for use with the Elos Accurate® Hybrid Base "" are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, ceramic material, milling machine and associated tooling and accessories. Elos Accurate Customized Abutment The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutment is compatible with the implant systems listed in table 1: Table 1. Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5 Astra Tech 3.0 | Ø3. | Ø3 Astra Tech EV 3.0 | Ø3 | Ø3 All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry 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 Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ are both patient-specific components designed for attaching to dental implants, providing a basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ will be attached to the implant using the included Elos Prosthetic Screw. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the pre-manufactured prosthetic component, the Hybrid Base in Titanium alloy per ASTM F136, as the bottom-half, and the zirconia superstructure as the top-half, which the laboratory/clinic is designing by use of the 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455), which when assembled comprises the finished medical device. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) While the Elos Accurate® Customized Abutment is a one-piece abutment which consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The same applies to the Elos Accurate® Hybrid Base™ which fits directly to an endosseous dental implant. The customized shape of the abutment is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility. The Elos Accurate library files for both Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ have built-in design limitations, and the user isn't allowed to exceed these limitations as follows: Customized Abutments: | Hybrid Base abutments (zirconia part): Min. wall thickness 0.4 mm | Min. wall thickness 0.5 mm Gingival height min. 0.5mm or max. 5 mm | Gingival height min. 0.5mm or max. 5 mm Max. angulation 20° or 30°. | Max. angulation 20°. Min. post height* 4 mm | Min. post height* 4 mm *The post height is defined as the cementable height of the abutment. The Elos Accurate® Customized Abutment and the Elos Accurate® Hybrid Base™ are both delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient.

The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutument is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: | Implant Platform compatibility | Platform diameter<br>[mm] | Implant Body diameter<br>[mm] | |--------------------------------|---------------------------|--------------------------------| | Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 | | Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 | | Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 | | Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 | | Biomet 3i Certain 4.1 | Ø4.1 | Ø4 | | Biomet 3i Certain 5.0 | Ø5 | Ø5 | | Biomet 3i Certain 6.0 | Ø6 | Ø6 | | Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 | | Straumann Standard WN | Ø6.5 | Ø4.8 | | Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 | | Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 | | Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device. The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits: - 1) Minimum wall thickness 0.5 mm - 2) Minimum post height 4.0 mm (for single unit restorations) - 3) Maximum gingival height 5.0 mm (min. GH of 0.5mm) - 4) Maximum angulation 20° The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw. The Elos Accurate® Hybrid Bas has a gold-colored anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K201860. Some of the prosthetic screws are uncoated and two screws are Medicarb coated, identical to the Medicarb coating in predicate device K201860. The subject uncoated screws are compatible with implant platforms Zimmer Screw-vent, Biomet 3i, Neodent GM and Straumann Standard RN and WN. The subject Medicarb coated screws are compatible with the implant platforms Hiossen ET Mini and ET Regular. The purpose of the coating is to lower friction in the thread connection and the screw seat connection. The Elos Accurate® Hybrid Base™ is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.

The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured according to a digital dentistry workflow. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: | Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] | |--------------------------------|------------------------|----------------------------| | Nobel Replace NP | 3.5 | 3.5 | | Nobel Replace RP | 4.3 | 4.3 | | Nobel Replace WP | 5 | 5 | | Nobel Replace 6.0 | 6 | 6 | | Nobel OC 3.0 | 3 | 3 | | Nobel CC NP | 3.5 | 3.5 & 3.75 | | Nobel OC RP | 3.9 | 4.3 & 5 | | Nobel CC WP | 5.1 | 5.5 | | Straumann Bone Level NC | 3.3 | 3.3 | | Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 | | Astra Tech 3.0 | 3 | 3 | | Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 | | Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 | | Astra Tech EV 3.0 | 3 | 3 | | Astra Tech EV 3.6 | 3.6 | 3.6 | | Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 | | Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 | | Astra Tech EV 5.4 | 5.4 | 5.4 | | Brånemark NP | 3.5 | 3.3 | | Brånemark RP | 4.1 | 3.75, 4 & 5 | | Brånemark WP | 5.1 | 5 & 6 | The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottom-half and the zirconia superstructure as the top-half. The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (i.e. 3Shape Abutment Designer Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits: 1) Minimum wall thickness 0.5 mm 2) Minimum post height 4.0 mm (for single unit restorations) 3) Maximum gingival height 5.0 mm 4) Maximum angulation 20° The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436) and the final prosthetic restoration is attached to the implant using a Prosthetic screw. The Elos Accurate® Hybrid Base™ is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in Table 1. All digitally designed zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility.

The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base. Manufacture of the final finished device will be at an Elos Medtech-approved milling facility that is registered with FDA as a medical device manufacturer and is qualified as a contract manufacturer to Elos Medtech. This submission includes a two-piece abutment (titanium base and zirconia superstructure) and abutment screws compatible with OEM implants from Dentsply Implants (Astra Tech TX, Astra Tech EV), Nobel Biocare (Nobel Active/Conical Connection and Nobel Replace) and Institut Straumann (Straumann Bone Level NC and RC). Abutments compatible with Astra Tech implants are available in engaging (anti-rotational) designs, and all others are available in both engaging and non-engaging designs.

The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1: Table 1. Elos Accurate Customized Abutment – Model Type | Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] ---|---|---|--- AB-ATO35 | Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 AB-ATO45 | Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 AB-ATE36 | Astra Tech EV 3.6 | 3.6 | 3.6 AB-ATE42 | Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 AB-ATE48 | Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 AB-ATE54 | Astra Tech EV 5.4 | 5.4 | 5.4 All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1: Table 1. Elos Accurate Customized Abutment – Model Type | Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] ---|---|---|--- AB-NBR43 | Nobel Replace RP | 4.3 | 4.3 AB-NBR50 | Nobel Replace WP | 5 | 5 AB-NBR60 | Nobel Replace 6.0 | 6 | 6 AB-NBA35 | Nobel CC NP | 3.5 | 3.5 & 3.75 All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1: Table 1. | Elos Accurate Customized<br>Abutment - Model Type | Platform compatibility | Platform diameter<br>[mm] | Implant Body diameter<br>[mm] | |---------------------------------------------------|-------------------------|---------------------------|-------------------------------| | AB-NBR35 | Nobel Replace NP | 3.5 | 3.5 | | AB-NBA30 | Nobel CC 3.0 | 3 | 3 | | AB-NBA43 | Nobel CC RP | 3.9 | 4.3 & 5 | | AB-NBA60 | Nobel CC WP | 5.1 | 5.5 | | AB-SBO33 | Straumann Bone Level NC | 3.3 | 3.3 | | AB-SBO41 | Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 | All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.