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The SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla in support of single or multiple unit restorations. The SMARTbase Abutment System integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTbase Abutment System consists of two major parts: the titanium base and zirconia top components make up a two-piece abutment. - SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors. - SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth replacement of mandbular and maxillary central and lateral incisors. - SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

The SMARTbase Abutment System is a two-piece engaging and non-engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). There are three device lines offered in the SMARTbase Abutment System: Legacy™ SMARTbase Abutment, InterActive™ SMARTbase Abutment, and SMARTbase Cylinder. The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm for Legacy™ and 3.0mm, 3.4mm for InterActive™, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The SMARTbase Cylinder is a two-piece non-engaging dental implant and multi-unit abutment cylinder comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The SMARTbase Cylinder is offered in two heights 9.0mm (that can be shortened to 4.0mm) and 4.0mm and in one width, platform diameters and collar (titanium base) height in order to accommodate different patient anatomies. The subject device is supplied with fixation screws that function as an extension of the implant or multi-unit abutment to which the SMARTbase Abutment or SMARTbase Cylinder is secured and is used with several accessories in digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools. The available design options for the zirconia top components to be provided either as a superstructure (to then receive a separate crown or bridge) or hybrid abutment-crown. There are three workflow options for fabricating the zirconia top component which fits the titanium abutment base: (1) end user creation of a press-ceramic material by conventional wax-up technique, (2) Implant Direct design and milling of zirconia in stock sizes using ceramic material of ZirCAD Prime (K142233) and provision of same to the end user, and (3) digital workflow using 3Shape or Exocad software where CAD design and milling of the superstructure or hybrid crown component is done at the end user's dental laboratory/office; the CAD design requires loading of Implant Direct's abutment design library to the 3Shape or Exocad software to design the superstructure or hybrid crown component within the established design limitations and specifications. The digital workflow includes use of the following products (not subject devices of this submission): - Ceramic material: ZirCAD Prime (K142233) . - . Cement: Maxcem Elite Self-Etch/Self-Adhesive Resin Cement (K060469) - . Composite: Kerr Harmonized (K151332) - Intra oral scanners: Medit Scanner, ITero Scanner Trios Scanner, CareStream . Scanner - Abutment design software: 3Shape Abutment Designer™ Software (K151455) and • Exocad AbutmentCAD Software (K193352) - . Milling machine: Wieland-Zenotec Select, Zenotec CAM, iCAM V5, and imes icore

Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and termediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading. Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or twostage surgical procedures. These implants are intended for use in partially and 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 loading when good primary stability has been achieved and with appropriate occlusal loading. The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns or bridges for edentulous or partially edentulous patients. Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients. The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations. InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate SMARTBase support for fixed bridgework. Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multipleunit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Legacy3 6mm Length consists of two-piece implants for one-stage or two-stage surgical procedures. There implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and 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 loading when good primary stability has been achieved and with appropriate occlusal loading. Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth restorations, recognizing bone stability and appropriate occlusal load requirements. The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function. Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandble or maxilla. Prostheses can be screw or cement retained to the abutment. The ReActive Dental Implant System are dental implant fixtures that are a part of a two-piece implant system. The ReActive implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements. ScrewIndirect Narrow Dental Implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met. The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The immediate loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met. The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restoration and support of overdentures. The implants are intended for immediate placement and function for multiple tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements. The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements. The Spectra Dental Implant System consists of one-piece implants for single-stage or two- stage surgical procedures that are intended for use in partially or fully edentulous mandillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established. The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.

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The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations. The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Legacy SMARTBase system consist of two major parts: the titanium base and zirconia top components make up a two-piece abutment. - . Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. - Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.

The Legacy SMARTBase Abutment is a two-piece engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The device is supplied with fixation screws that function as an extension of the implant to which the SMARTBase is secured, and is used with several accessories in conventional and digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools. The Legacy SMARTBase Abutments allow for patient-specific designs through conventional and digital restoration materials and methods. The final restorations are designed and produced under the direction of a clinical professional and are based on requirements provided to Implant Direct or the preferred laboratory in digital or stone model form. The restoration (crown) is designed to fit on top of the SMARTBase abutment using off-the-shelf 3Shape software (K151455). The reference device, 3Shape Abutment Designer Software (product code PNP), provides the digital design as an accessory to the physical dental abutment. The CAD design requires loading of the Implant Direct abutment design library via the 3Shape server to the 3Shape Software in order to design the zirconia top component within the established design limitations and specifications. The 3Shape software provides a digital design output file that is used for fabricating the finished device. The digital workflow includes the following products (not subject devices to this submission): - Ceramic material: Zenostar MT ● - Cement: EMBRACE Wetbond Resin Cement (K071278) ● - Intra-oral scanner: 3M Tru-Definition (K122467), ITero Scanner (K131101) . - Lab scanner: 3Shape D700 & 3Shape Scan-it Restoration Dental System (510(k) exempt, . product code NOF) - . Abutment design software: 3Shape Abutment Designer™ Software (K151455) - Milling machine: Wieland-Zenotec Select & Zenotec CAM . The device is single-use and supplied non-sterilization by the end user. It is an externallycommunicating device which comes in permanent contact (>30 days) with a patient's tissue/bone.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate SMARTBase support for fixed bridgework. The 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 SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. - Narrow Diameter (3.2. 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

The InterActive SMARTBase abutments system is a line extension of the previously cleared Implant Direct device, 2014 InterActive/SwishActive Implant System. The InterActive SMARTBase abutments are comprised of engaging abutments, non-engaging abutments, modified zirconia engaging abutments, modified zirconia non-engaging multiunit bridges, and fixation screws that are intended to function as an extension of the implant. The proposed SMARTBase Abutment is a two-piece abutment consisting of titanium base and zirconia top components. To fabricate the zirconia top component that fits the titanium base, there are three workflow options: (1) using a press-ceramic material that is formed by conventional wax-up technique by the end user, (2) the zirconia top component is designed and milled by Implant Direct in stock sizes and provided to the end user to be placed on the titanium base for forming two-piece abutment, and (3) digital workflow using 3Shape where CAD design and milling of the zirconia top component is done at the end user's dental laboratory/office to be placed on the titanium base. The CAD design requires loading of Implant Direct abutment design library to the 3Shape Software to design the zirconia top component within the established design limitations and specifications.

GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

GPS® Angled Abutments are designed to be used in conjunction with dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The proposed GPS® Angled Abutments are intended to provide extra prosthetic options currently unavailable to the clinician. The proposed abutments are intended to complement the cleared systems listed in Table 2 below. The proposed abutments have the same compatible implant interface specific to each implant system and platform size. The GPS® Angled abutments have the same coronal GPS Angled Top for all proposed GPS® Angled abutments. The GPS top has a superior outer radius at its coronal region that is identical to the primary predicate GoDirect implants (K090234 - Spectra System Dental Implants 2008). The proposed GPS® Angled abutments are a two-piece design having an identical lower piece with same interface features and angles as the reference predicate InterActive screw receiving angled abutments with a ball top (K130572 - InterActive/SwishPlus2 Implant System).

InterActive/SwishActive Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and 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 loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. These implants are also indicated for multiple tooth replacements or denture stabilization. Compatibility: InterActive and SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.

The 2014 InterActive/SwishActive System is a line extension of the previously cleared Implant Direct Sybron Manufacturing LLC, InterActive/SwishPlus2 Implant System (510K #130572) on December 24th, 2013). The name of the SwishPlus2 implants is changing to SwishActive and the Indications for Use within this submission has been revised from previous submission to only reflect the name change. In addition, the previously cleared InterActive/SwishActive implants have been tested with NobelActive titanium 30 degree angled abutments to expand the indication for use as the test results show that the InterActive/SwishActive implants are prosthetically compatible with NobelActive NP (Narrow Platform -3.0mm diameter) and NobelActive RP (Regular Platform - 3.4mm diameter) titanium abutments with up to 30 degree angulations. Furthermore, the InterActive 30 degree abutments have been tested with NobelActive implants to expand the indication for use as the test results show that the InterActive abutments are prosthetically compatible with NobelActive NP (Narrow Platform - 3.0mm diameter) and NobelActive RP (Regular Platform -3.4mm diameter) implants with up to 30 degree angulations. Lastly, the 2014 InterActive/SwishActive System within this submission offers additional abutments that are intended to provide extra prosthetic options to the implant line. These abutments consist of two categories: (1) GPS straight abutments, and (2) Zirconia straight, angled, and modified Abutments. GPS abutments are used in attachment-retained, tissue supported restorations where the patient is fully or partially edentulous in the arch to be restored. These abutments are sold non-sterile with an accompanying Instructions for Use that provides clinicians with pre-use sterilization instructions. These abutments are made from Titanium 6AL-4V ELI with the coronal region having a Titanium Nitride (TiN) coating The TiN coating process was validated through cytotoxict y testing in accordance with ISO 10993-5. The Straight GPS abutments are a one-piece design secured to the implant having identical interface features as the previously cleared InterActive Ball Abutments (K130572) These abutments are available in 1,2,3,4, 5 and 6mm in height. Zirconia abutments are intended for use in partially or fully edentulous mandible and maxillae in support of single or multiple unit cement retained restorations. The abutments consist of two pieces, the titanium base and the zirconia top. The Zirconia abutments have identical interface features as the previously cleared devices InterActive Cement Retained Abutments and Titanium Non-Engaging abutments (K130572). The abutments have a titanium base that has hex engaging and non-engaging implant/abutment interface having identical specifications as the previously cleared InterActive titanium abutments (K130572). The abutments have a coronal zirconia portion that is straight, angled, or it can be modified by the company to specific patient needs. The modifications to the top are restricted to minimal requirements: a maximum angle of 30° from the axis of the implant, a minimum wall thickness of 0.4mm, a minimum post height of 4mm, and a minimum cuff height from the interface of 0.7mm which are identical minimal requirements specified in the Instructions For Use for the previously cleared InterActive/SwishPlus2 abutments (K130572). These abutments are sold non-sterile with an accompanying Instructions for Use that provides clinicians with pre-use sterilization instructions.

InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and 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 loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization. Compatibility: InterActive and SwishPlus2 implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.

The InterActive/SwishPlus2 Implant System consists of InterActive implant, SwishPlus2 implant, abutments, healing components, and screws for use in one or two-stage placement and restorations. The InterActive implants are two-stage implants that offer four body diameters (3.2, 3.7, 4.3 and 5.0mm) in six lengths (All 6 thru 16mm except for the 3.2 which is 8-16mm). The SwishPlus2 implant body diameters (3.3, 4.1, 4.8, and 5.7mm) in six lengths (All 6 thru 16mm except for the 3.3mm which is 8-16mm). The InterActive dental implant is a tapered screw-type endosseous with an external thread configuration consisting of double-lead threads over the body of the implant and 2mm of quadruple lead mini-threads near the coronal portion of the implant. The implant body features an even taper from the apical along its body and a straight walled coronal aspect. The implants offer two interface diameters (3.0mm and 3.4mm) which are identical to the interface of the predicate devices, NobelActive implants, having a conical leading bevel and an internal hex engaging surface. The SwishPlus2 dental implant is a screw-type endosseous with an external thread configuration consisting of single lead threads over the body of the implant and 2mm of micro-grooves near the coronal portion of the implant. The implant body features an even taper at the apical end and a straight wall coronal aspect. The SwishPlus2 (two-stage) implant offer two interface diameters (3.0mm and 3.4mm) which are identical to the interface diameters of the predicate devices, NobelActive implants, having a conical leading bevel and an internal hex engaging surface. The InterActive/ SwishPlus2 implants are available with two surface coatings: SBM Blast and HA Coating.

Legacy3 6mm Length consists of two-picce implants for one-stage on two-stage surgical procedures. These implants are intended for use in partially and 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 loading when good primary stability has been achieved and with appropriate occlusal loading.

The Legacy3 6mm length implants consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and 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 loading when good primary stability has been achieved and with appropriate occlusal loading. The Legacy3 6mm length implants have a taper body to facilitate insertion in an undersized socket and gradual expansion of bone to increase initial stability. The body has double-lead buttress threads and quadruple-lead threads in the coronal region. The body offers two surface options: Soluble Blasted Media (SBM) texture throughout the entire length or SBM at the coronal section plus HAcoated the rest of the body length. The internal connection consists of leading bevel, a hex and a 1-72UNF thread to engage the mating components. The Legacy3, 6mm length implants are a line extension to the previously cleared Legacy implants (K090234) having identical prosthetic interface compatibility. The addition is not due to recall, customer complaint, corrective action, or labeling and it does not affect its intended use. The addition provides a shorter version of the predicate implant in order to allow for a restoration option in areas of the mouth where an 8mm implant will not work. The shorter version required minor changes to the outer body design taper and threads depth to allow for adequate thread engagement when using existing surgical protocol and have a surface area that is equal or greater than the predicate devices. The shorter 6mm length implants are equivalent to the existing SwishPlant 6mm implants (K081396) with clinically proven safety and efficacy. The Legacy3 6mmL implants offer six body diameters (3.7, 4.2, and 4.7, 5.2, 5.7 and 7.0 mm) in 6mm length with the platform diameter of 3.5, 4.5 and 5.7mm. The Legacy3 6mmL implants are available with two surface coatings: SBM Blast and HA Coating. The Legacy3 6mm implants are surgically and functionally compatible with the previously cleared prosthetic components (K060063, K081101, K090234 and K061319), and currently marketed laboratory components and surgical armamentaria.