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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to expand the DESS Dental Smart Solutions for the DESSLoc Attachment system cleared under K170588, K191986, K212628, K222288, K240208, and K242340 and to:

• include OEM platform compatibilities to the DESSLoc Abutment design that have been previously cleared in other DESS Abutment designs,
• include new OEM platform compatibility for MIS C1 Dental Implant System,
• include attachment components (retention inserts and housing) including reprocessing information in labeling.

The DESSLoc Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) for resilient attachment of prostheses to endosseous dental implants. There have been no changes to the design of the DESSLoc abutments, the design is the same that has been cleared in the above submissions. The abutments are made of titanium alloy and coated with zirconium nitride (ZrN). The nylon retention insert is manufactured from Polynil® (polyamide 6.6) or Vestamid® Care ML GB30 (polyamide 12). The denture housing is made of titanium alloy with a machined surface or anodized surface. The DESSLoc abutment is compatible with OEM implants, as listed below.

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DESS® Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add abutments to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K242340 and K240208. The subject device abutment designs include Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), and abutment screws.

Pre-Milled Blank Abutments are designed for custom abutment fabrication by a CAD-CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. The Pre-Milled Blank Abutments have a maximum (before milling) diameter of 10 mm or 14 mm and a solid cylindrical design with an engaging or non-engaging implant connection. They are available in versions with a straight screw channel and with an angled screw channel for esthetic considerations. The Pre-Milled Blank Abutments are manufactured from titanium alloy (Ti 6Al-4V).

The design parameters for the CAD-CAM fabrication of a custom abutment from the Pre-Milled Blank Abutment are:

• Minimum wall thickness – 0.45 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 6.0 mm
• Pre-Milled Blanks are for straight abutments only

Multi-Unit Abutments: Straight and Angled are designed for attachment of multi-unit screw-retained restorations and are provided in three (3) designs, straight (0°), angled 17°, and angled 30°. The designs of the subject Multi-Unit Abutments are similar to the designs of Multi-Unit Abutments cleared in K242340 and K240208. All Multi-Unit Abutments are manufactured from titanium alloy (Ti-6Al-4V).

The subject device straight Multi-Unit Abutments have a non-engaging, threaded design that attaches directly to the implant. The subject device straight (0°) Multi-Unit Abutments are included in this submission are similar in design to straight Multi-Unit Abutments cleared in K242340, K230143, and K222288. Subject device straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 1 mm to 5.5 mm.

The subject device angled Multi-Unit Abutments are provided only in an engaging design that requires an abutment screw. The subject device Multi-Unit Abutments angled 17° and 30° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 2.5 to 4.5 mm.

Select straight and angled Multi-Unit Abutments have an added coating of zirconium nitride (ZrN). This coating is identical to the ZrN coating used on abutments with ZrN cleared in K242340.

DESS® Dental Smart Solutions Screws are designed to attach the abutment to the implant or the prosthesis to the abutment. There are a total of seventeen (17) subject device screws compatible with the subject device components or previously cleared components. The new screws have designs that are similar to those of screws cleared in K242340 and K240208. Screws are made of titanium alloy (Ti-6Al-4V). Select subject device screws are available with DLC (Diamond-like Carbon) coating and are identical to that used on screws cleared in K240208.

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Adin Customized Abutments are intended for use with Adin dental implants in partially or fully edentulous mandibles and maxillae, as a support for single-unit or multiple-unit screw-retained or cement-retained restorations.

All digitally designed abutments for use with Adin Ti-base and Adin Ti-blanks are intended to be sent to an FDA-registered Adin Dental Implants validated milling center for manufacture or to be manufactured according to the digital dentistry workflow, which integrates multiple components: scans from desktop and intraoral scanners, CAD and CAM software and a milling machine with associated accessories.

The purpose of this submission is to obtain marketing clearance for Adin Customized Abutments, a series of components compatible with dental implants from Adin Dental Implant Systems Ltd., intended for use in the fabrication of patient-specific abutments. The subject device components include CAD CAM abutments (Ti-bases, Ti-blanks). All patient-specific abutment fabrication is by prescription on the order of the clinician. Fabrication of patient-specific abutments will be performed at validated milling centers or, by using a validated digital dentistry workflow, at point-of-care facilities.

The design and fabrication of the zirconia superstructure for Ti-bases or of patient-specific abutments from Ti-blanks will be conducted using a digital dentistry workflow requiring the use of the following equipment and software:

Scanner: iTero Intra Oral Scanner or Medi Corp. Identica 3D Desktop scanner
Design Software: EXOCAD AbutmentCAD design software (K193352)
CAM Software: WORKNC Dental
Milling Machine: Ceramill Motion 2.

The superstructures to be used on Ti-bases are to be made from the following material and are to be cemented as follows:

Zirconia Material: ArgenZ Ultra (K071410)
Cement: PANAVIA V5 (K150704).

The abutments are provided non-sterile and are intended to be cleaned and steam-sterilized by the clinician prior to use according to the instructions given in the Instructions for Use (IfU) accompanying the device.

No compatibility with implants other than those from Adin Dental Implant Systems Ltd. is claimed or intended. Ti-bases are compatible with Adin Dental implants cleared in K081751 and K223714. Ti-blanks are compatible with Adin Dental implants cleared in K081751, K153111, K140293, and K112585.

Ti-base abutments are two-piece abutments, with the base component cemented to a CAD CAM fabricated zirconia superstructure. The final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. Each patient-specific superstructure is individually prescribed by the clinician.

Ti-base abutments are provided with a compatible abutment screw that retains the base to the implant (the restoration is screw-retained on the implant level). The manufactured superstructure is attached to the Ti-base.
Engaged Ti-bases include anti-rotational connections that engage with the dental implant and are intended for single tooth restorations. Non-engaged Ti-bases include round connections that do not limit rotation and are intended for multi-unit/bridge restorations. Ti-base Angular are provided only in engaging designs.

The all-metal Ti-base components are straight with regard to the implant axis. Angular Ti-base includes an angled upper portion that allows the screw channel either to be straight relative to the implant axis or to be angled to allow for moving the screw channel in an oral direction (up to 20°) for esthetic purposes.

All Ti-bases are color coded per platform by an anodizing process for easier identification. Adin Ti-bases are available for Adin implant platform connections (standard internal hex – RS, and UniFit - UF)

The all-metal Ti-base components are provided in engaging and non-engaging versions with gingival heights ranging from 0.65 mm to 4.0 mm. They are provided with post heights of 4.0, 6.0, and 8.0 mm. Ti-base Angular is a component with gingival heights ranging from 1.0 mm to 3.0 mm, provided in an engaging design. Ti-base Angular includes an angular cutout in the post to allow for moving the screw channel in an oral direction for esthetic purposes. It is provided with post heights from 4.0 mm to 8.0 mm.

The design parameters for the CAD CAM zirconia superstructure to be used on Ti-base and Ti-base Angular, are:

• Minimum wall thickness – 0.5 mm
• Minimum post height for single unit restorations – 4.0 mm
• Minimum gingival height – 0.0 mm
• Maximum gingival height – 4.5 mm
• Maximum angulation of the final abutment - 20°

Adin Ti-blank abutments include on one side a pre-fabricated connection for the dental implant and on the other side a pre-fabricated connection to the milling machine blank holder. They are available in diameters of 11.5 mm and 15.8 mm and are provided with a compatible abutment screw.

All Ti-blank designs are subject devices to be manufactured using a CAD CAM workflow. Ti-blank abutments are provided in engaging and non-engaging designs, are available for all Adin implant platform connections, and are made of titanium alloy (Ti 6Al 4V).

The design parameters for Ti-blanks are:

• Minimum wall thickness – 0.7 mm for RS; 0.5 mm for UNP, NP, RP, WP
• Minimum post height for single unit restorations – 4.0 mm
• Maximum milled abutment height above implant level – 10 mm
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 4.0 mm for RS; 1.0 mm for UNP; 3.0 mm for NP, RP, WP
• Maximum angulation of the final abutment – 25° for RS, NP, RP, WP; 15° for UNP

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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components previously cleared K200992, K193096, K170398 and K170392.

This submission adds Interface Abutments and Healing Abutments to the S.I.N. Dental Implant System. The subject device Interface abutments are provided with MT 16º and CM11.5º connection compatible with the S.I.N. Dental implants.

Subject Device Interface Abutments

Subject device Interface Abutments are two-piece abutments for which the second part (or top half) is the ceramic superstructure. The second part is designed and manufactured using CAD-CAM techniques. The titanium component of the Interface Abutments has a cementable platform diameter of 3.5mm, 4.0mm, 4.5mm, or 5.5mm, cementable post-height of 4.0mm or 6.0mm, and a gingival height built into the titanium base component from 0.5mm to 4.0 mm. The two pieces of the Ti-Base are bonded using Panavia Universal Dual-Cure Cement (K150704), as referenced in K190936.

All subject devices are provided only in straight designs, with no pre-angled conventional abutments or pre-angled CAD-CAM abutments. No subject device abutment is to be customized to create an angled abutment or to correct for angulation, and no superstructure for use with any subject device Interface abutment (CAD-CAM) is to be fabricated to create a final abutment with angulation or to correct for angulation. Therefore, this model has a slight design difference to improve screw insertion and removal. It was purposely designed to optimize fixation and removal of the screw connection. This new presentation allows screw fixation even in cases of anterior aesthetic rehabilitation, avoiding the need to create screw access holes in the sublingual phase. However, it is confirmed that all implant-abutment interfaces are intended exclusively for straight configurations and are not indicated for any angled model. These minor differences in the exact dimensions of the subject device interface abutment as compared to the predicate device and reference devices do not impact safety, effectiveness, or substantial equivalence.

The subject device interface abutments with the CM11.5º interface are compatible with implants cleared in K200992, K221453, K211921 and K170392 in terms of abutment-implant connection. The subject device with the MT16º interface is compatible with implants cleared in K222231, K193096 and K170392 in terms of abutment-implant connection.

The design parameters for the CAD-CAM fabrication of patient-specific abutments from CADCAM Abutments are the same for the 11.5° CM implant connection and the MT 16° implant connection. The design limit parameters are:

• Minimum wall thickness – 0.5 mm
• Minimum abutment post height for single-unit restoration – 4.0 mm
• Maximum angle – 0°. Straight only
• Maximum angle for screw insertion/removal – 20º
• Maximum gingival height – 5.0mm
• Minimum Gingival Height – 0.5 mm
• Maximum allowable abutment Post Height – 6 mm
• Total Abutment Height – 10mm

By definition, the abutment post height is considered by FDA to be the "stump" portion above the gingival collar, to which the restorations attach.

All subject device Interface Abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and the same zirconia that is specified for superstructures in K190396, and are to be used with subject abutment screws. All subject devices are provided sterile. All Interface abutments are provided sterile by gamma irradiation; the same sterilization method used in predicate device K190396 and in the additional devices K200992 and K170392.

All Interface abutments manufactured form titanium alloy are anodized using a standard anodization process is identical to the anodization process used on abutments cleared in K190396.

The subject device abutments screws are to be used with Interface Abutments present in this submission and they are substantially equivalent to material (titanium alloy) and designs to abutments screws cleared in K170392.

Subject Device Healing Caps

The subject device Healing Cap is substantially equivalent to the corresponding design Healing Cap cleared in K170392. The subject device healing cap is designed for the healing period between implant placement and final abutment placement and is not intended to support a temporary prosthesis.

All Healing Caps are provided sterile by gamma irradiation; the same sterilization method used in predicate device K170392 and additional predicate device K200992.

All subject device components are provided sterile by gamma irradiation, the same sterilization method used in K190936, K170392 and K200992.

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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:

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. The 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 bottom-half 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:

*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 driver intended to be used with the Elos Accurate® Hexalobular Prosthetic Screws is the Elos Prosthetic Screwdriver 18mm, 26mm or 34mm (Ref. No. 042.0018, 042.0026 or 042.0034). 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 K242025.

The subject prosthetic screws are provided are either non-coated or surface coated with DLC (identical to the DLC coating in reference device K201860).

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 packed in 1 pc. packaging with the Elos Accurate® Hexalobular Prosthetic screw. The Screw is also available packed alone in 1 pcs packaging.

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Bonafix Implant Abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

All digitally designed superstructures, and/or hybrid crowns for use with Titanium Base are to be sent to a Bonafix validated milling center for manufacture.

Bonafix Abutment Solutions are a dental implant abutments system that includes three abutment design types (Temporary, Straight Ti-Base and Multi-Unit), that can be used to support single-unit or multi-unit prosthetic restorations. These abutments incorporating interface features compatible with sixteen (16) endosseous dental implant system platforms (Eight (8) designs from five (5) manufactures). The subject device abutments platform diameters range from 3.5mm to 6.3mm, and the corresponding compatible implant body diameters also range from 3.5 mm to 6.3mm. The system also includes corresponding abutment screws.

Temporary Abutments are manufactured from Titanium Grade 5 and consist of a coronal section, a platform and a connection part. The abutments are provided non-sterile with instructions for end user sterilization. The Temporary Abutments are seated in the implant with a prosthetic screw which is also manufactured from Titanium Grade 5. The prosthetic screw is delivered with the abutment. Angular correction of temporary abutments and placement of implant bodies at an angle is not allowed, they must be used parallel to the direction of occlusal loading forces. Temporary Abutments can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Modifications can be made by the end-user only in the minimum post height. Minimum post height – 4.0 mm. Temporary Abutments have a maximum duration of usage of 180 days.

The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The superstructure are fabricated using a CAD/CAM process in Zirconia. The apical end is prefabricated to fit the compatible implant platform, as shown above, and is available with implant connections for crowns (with socket) or bridges (without socket). Angular correction of abutments and placement of implant bodies at an angle is not allowed, they must be used parallel to the direction of occlusal loading forces. Each abutment is provided with a screw designed to fit the compatible implant. The design parameters for the fabrication of the zirconia superstructure, which are already locked in the CAD/CAM software, are as follows: Minimum wall thickness – 0.45 mm, Minimum abutment post height – 4.0 mm, Maximum abutment post height – 6.5mm, Maximum gingival height – 5.0 mm, Minimum gingival height – 0.7 mm, Angulation – 0°. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356. The required cement for bonding the zirconia superstructure to the Bonafix TiBase abutments to create the final two-piece abutment is G-CEM LinkAce™ cleared in K120243. Bonafix Ti-Base Abutments are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) with the superstructure made of zirconia conforming to ISO 13356 Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

The Multi-unit abutments are screw-attached to the implant to restore fully or partially edentulous arches. Their use is not intended for single-unit crowns. They are designed with various gingival heights (1.5, 2.5 and 3.5mm) and can be screwed directly to a compatible implant. They use a titanium Multi-unit sleeve, which is cemented to the prosthesis. Together with a titanium prosthetic screw, the prosthesis is ready to be screwed onto the Multi-unit abutment, which in turn is screwed onto the implant, thus completing the restoration. This multi-unit abutments are not intended to provide angle or divergence correction. For all system, are manufactured from Titanium Grade 5. Multi-unit sleeve can only be modified in the post height and that the minimum post height is 4mm from gingival collar.

The Prosthetic screw is used to seat all abutments for the system, included the temporary abutments and ti-bases, to the dental implant. They are provided along the prosthetic components, but they are also provided as standalone screws. The Abutment screws are manufactured from titanium alloy conforming to ASTM F136.

All system abutments are provided non-sterile with instructions for end user steam sterilization. The subject devices are provided non-sterile and required to be sterilized. All Bonafix TiBase abutments are packaged into PET bag.

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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.

The purpose of this submission is to expand the indications of the LOCATOR® Angled Abutment product line to include use with new dental implant systems. This was achieved through collaboration with the implant manufacturers BioHorizons and Implant Direct to prove compatibility of the design of the implant to abutment connection, and equivalence of design specification and performance characteristics.

Previously, the LOCATOR Angled Abutment has been cleared by FDA in applications K233587, K243272, and K250721 for use with various dental implant systems by the manufacturers BioHorizons, Implant Direct, Implant Logistics, Neodent, Nobel Biocare, Straumann, and ZimVie (Zimmer). These LOCATOR Angled Abutments are also designed and cleared for use with removable LOCATOR® Attachment Systems (K072878) and LOCATOR FIXED® (K213391), intended for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla. This 510(k) submission expands the indications of the LOCATOR Angled Abutment product line with new connections compatible with the following implant systems from BioHorizons (Camlog) and Implant Direct.

• BioHorizons Tapered 3.0 (Internal Hex)
• BioHorizons Tapered Pro Conical Narrow platform (CONELOG)
• BioHorizons Tapered Pro Conical Regular platform (CONELOG)
• BioHorizons Tapered Short Conical Regular platform (CONELOG)
• Implant Direct Legacy 3, 3.0mmD

Compatibility of the new LOCATOR Angled Abutments and screws with either the BioHorizons or Implant Direct implants has been demonstrated through documented collaboration with the OEM. This was achieved by utilizing the OEM's design specifications, which were shared with Zest to create a LOCATOR Angled Abutment and screw that is equivalent to the implant manufacturer's own abutment device in how it interfaces with their respective implant system(s). Additionally, the LOCATOR Angled Abutment parameters deemed critical to ISO 14801 fatigue testing are also equivalent to the manufacturer's cleared abutment specifications, and therefore do not create a new worst case construct or condition. An equivalent specification is deemed as being identical to or within the OEM's defined specification.

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Customized Abutment and Screw is used as a complement component for dental implants placed in the jawbone after tooth loss, to connect, support and retain the restoration or implant superstructure. Customized Abutment and Screw is indicated for single unit restorations.

Customized Abutment and Screw is compatible with following Implant Systems:

All digitally designed abutments for use with Customized Abutment and Screw are intended to be manufactured at a BESMILE validated milling center.

The Customized Abutment and Screw is composed of two parts: the customized abutment and screw. Among them, the customized abutment is machined from Ti-6Al-4V titanium alloy material in accordance with ASTM F1472, and the screw is machined from Ti-6Al-4V ELI titanium alloy material in accordance with ASTM F136. And the surface of product is not modified. The lower part of the product has a fixed interface shape, and the upper part is machined according to the needs of the patient. In the process of dental implant surgery, as the upper structure of the implant, it is installed on the implant platform anchored in the bone, which plays the role of supporting, retaining and stabilizing the prosthesis.

Customized Abutment and Screw is created via use of the Pre-milled Blank.

The information of the Implant Systems compatible with the product is detailed in Table 1.

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IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments, screws, as well as other dental abutment accessories, intended to be placed into dental implants to provide support for dental prosthetic restorations.

Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems.

IPD Dental Implant Abutments includes the following categories of dental abutment designs:

• Titanium base (Interface) abutments (INC3D);
• Multi-Unit abutments (MUA);
• Overdenture Abutments (PSD);
• Temporary Abutments (PP);
• Healing Abutments (TC).

The system also includes the use of the corresponding screws intended to attach the prosthesis to the dental implant. Specifically:

• Ti Screw (TT): Used during restoration fabrication.
• TiN Screw (TTN): Used in finished restorations, with TiN coating.
• TPA Screw (TPA): Used in finished angulated restorations, with TiN coating.

The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implant for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".

The purpose of this submission is to expand IPD Dental Implant Abutments offerings with:
• New IPD's compatible dental implant systems,
• New angulations available abutment-category specific.
• New in-house TiN coating.

IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
(Table 2. Summary of IPD abutments categories with compatibilized OEM Implant/Abutment Systems with specific reference to maximum angulation specifically included in this submission. provided in original text)

Ti Base (Interface) abutments are attached (screw-retained) to the implant/abutment and cemented to the zirconia superstructure.

The Ti Base is a two-piece abutment composed of the titanium component, as the bottom-half, and the zirconia superstructure, as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDA-cleared design software (3Shape Abutment Designer™ Software, cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care, or at a dental laboratory.

The design and fabrication of the zirconia superstructure for Ti Base (Interface) will be conducted using a digital dentistry workflow requiring the use of the following equipment, software and materials:
Scanner: 3D Scanner D850.
Design Software: 3Shape Abutment Designer Software, K151455.
Zirconia Material: DD Bio Z, K142987.
Milling machine/Brand: Dental Concept System Model: DC1 Milling System.
Cement: Multilink® Automix, K123397.

Ti Base (Interface) abutment design parameters for the zirconia superstructure are defined as follows:
Minimum gingival height: 1.5 mm
Minimum wall thickness: 0.43 mm
Minimum post height for single-unit restorations: 4.75 mm (1)
Maximum gingival height: 6.0 mm
Maximum angulation of the final abutment 30° (2)

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 provided FDA 510(k) clearance letter pertains to IPD Dental Implant Abutments, a medical device, not an AI/ML-driven software product. Therefore, the information requested regarding acceptance criteria and study data for an AI/ML device (e.g., sample size for test/training sets, expert ground truthing, MRMC studies, standalone performance) is not applicable to this document.

The document describes the device, its intended use, comparison to predicate devices, and the non-clinical performance testing conducted to demonstrate substantial equivalence. These tests are physical and chemical in nature, not related to the performance of an AI/ML algorithm.

Here's a breakdown of why an AI/ML-focused response is not possible, based on the provided text:

• Device Type: The device is "IPD Dental Implant Abutments," which are physical components used in dentistry (titanium alloy abutments, screws, designed for zirconia superstructures). It is not software, a diagnostic imaging tool, or an AI/ML algorithm.
• Purpose of Submission: The submission aims to expand compatibility with new dental implant systems and include new angulations and in-house TiN coating. This is a modification of a physical medical device, not a new AI/ML development.
• Performance Data (Section VII): This section explicitly lists non-clinical performance testing such as:
  • Sterilization validation (ISO 17665-1)
  • Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993)
  • Reverse engineering and dimensional analysis for compatibility
  • Validation of the digital workflow and software system (but this refers to the CAD/CAM software used to design the physical abutments, not an AI/ML diagnostic tool)
  • Static and dynamic fatigue testing (ISO 14801)
  • Modified Surfaces Information
  • MRI safety review

Conclusion:

The provided document describes a 510(k) clearance for a physical dental implant component. It does not contain any information about the acceptance criteria or study design for an AI/ML driven medical device. Therefore, a table of acceptance criteria and reported device performance related to AI/ML, sample sizes for test/training sets, details on expert ground truthing, MRMC studies, or standalone performance of an algorithm cannot be extracted from this text.

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