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Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture. Sherlock abutments are compatible with the implant systems listed in the Compatibility Table: **Compatibility Table** | Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) | |---|---|---| | Neodent Helix GM®, Drive GM®, Titamax GM® | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | 3.0 |

Sherlock is a dental implant abutment system that is being expanded to include a new compatible implant system, Neodent GM®. The Subject device implant platform diameter is 3.0 mm, and the corresponding compatible implant body diameters range from 3.5 mm to 7.0 mm. The abutment designs are Titanium Base, Titanium Blank, Straight Multi-Unit, Multi-Unit Angled 17°, and Multi-Unit Angled 30° Abutments. These abutment designs were previously cleared in the sponsor's K220482 Predicate device and K212664 Reference device submissions. All abutment designs are provided with corresponding abutment screws. The Subject device Titanium Base abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (prefabricated titanium base component) with a cemented/bonded CAD-CAM fabricated zirconia top-portion (superstructure) where the final two-piece abutment (base component and cemented superstructure) is the finished device used for the prosthetic restoration. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center. All Subject device prefabricated titanium base components are provided in a straight design with no angulation in the titanium base post. They are provided with either an indexed/engaging implant connection for crowns or a non-engaging/nonindexed implant connections for bridges. The standard prefabricated titanium base components are provided in gingival heights ranging from 0.8 mm to 3.0 mm and abutment post lengths of 8 mm or 10 mm. The ASC prefabricated titanium base components are provided in gingival heights ranging 0.8 mm to 2.5 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC prefabricated titanium base components are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard prefabricated titanium base components and ASC prefabricated titanium base components posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters. The overall design parameters for the two-part Standard and ASC CAD/CAM prefabricated titanium base components with zirconia mesostructure are: - Minimum Zirconia Wall Thickness – 0.5 mm - Minimum Post Height for single-unit abutment* – 4.0 mm - Minimum Overall Gingival Height – 0.8 mm (titanium base plus zirconia) - Maximum Overall Gingival Height – 5 mm - Maximum Correction Angle – 30° The required cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704. Titanium Blank abutments, sometimes referred to as "Pre-mill" or "Ti-Blank" abutments are one-part abutments intended for use in a CAD/CAM workflow. Each Subject device Titanium Blank implant abutment has a pre-manufactured indexed implant connection interface with a cylindrical customization section and a milling retention geometry section. The retention geometry holds the component in a milling machine fixture while the patient-specific portion above the implant interface is milled in a dental milling machine. All patient-specific Titanium Blank abutment fabrication is by prescription on the order of the clinician. The overall design parameters for the Titanium Blank customized abutments are: - Minimum Wall Thickness – 0.75 mm - Minimum Post Height for single-unit abutment* – 4.0 mm - Minimum Overall Gingival Height – 0.8 mm - Maximum Overall Gingival Height – 5 mm - Maximum Correction Angle – 30° All digitally designed zirconia mesostructures for use with the Subject device titanium base abutments and digitally designed Subject device titanium blank abutments will be fabricated at an Open Implants validated milling center under FDA quality system regulations. Multi-Unit Abutments (MUAs) are intended for use with multi-unit restorations. They are considered two-part abutments. The base portion of the MUA is connected directly to the implant either with an integral screw (straight MUA) or with a separate multi-unit abutment screw (angulated abutments). Straight MUAs have a non-indexed connection with the dental implant. The angulated MUAs have an indexed connection with the dental implant. The second part of the MUA is a mating coping which is retained with a prosthetic screw. Multi-Unit Abutments are available in Straight, 17° Angulated and 30° Angulated configurations. The coping and prosthetic screw is compatible with each MUA design/configuration. All Subject device abutments and corresponding abutment screws are pre-manufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and are provided non-sterile to the user. The mesostructure/copings for Titanium base abutments are fabricated from zirconia conforming to ISO 13356, Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants: | Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name | |---|---|---| | Straumann Bone Level (CrossFit® Morse Taper) | 2.9 | SC | | | 3.3 | NC | | | 4.1, 4.8 | RC | | Straumann® Tissue Level (CrossFit® Connection) | 3.3, 4.1, 4.8 | RN | | | 4.8 | WN | | Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB | | | 5.0, 5.5, 6.5 | WB | | Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from four (4) manufacturers, and a total of eight (8) implant-abutment interface compatibilities. The subject device prosthetic platform diameters range from 3.8 mm to 6.9 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K222368. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate. Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant. All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations. MIST IC L-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD-CAM customized restoration where the superstructure produced will compose the second part of the two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided with engaging and non-engaging connections. The L-LINK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement required in the labeling (RelyX RMGIP bonding cement, cleared in K022476). The design parameters for L-LINK patient-specific abutments are: - Minimum wall thickness – 0.5 mm - Minimum cementable post height for single-unit restoration – 4.0 (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 (for all except Straumann BLX L-Link) – 5.0 mm - Maximum gingival height (for Straumann BLX L-LINK) – 6.0 mm - Maximum angle – 20° All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356. MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection. The design parameters for PREFIT patient-specific abutments are: - Minimum wall thickness – 0.5 mm - Minimum cementable post height for single-unit restoration – 4.0 (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 (for all except Straumann BLX PREFIT) – 5.0 mm - Maximum gingival height (for Straumann BLX PREFIT) – 6.0 mm - Maximum angle – 30°

Geo Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit cement-retained prosthesis in the mandible or maxilla. Geo Abutments are compatible with the following implants. All digitally designed custom abutments for use with Geo Abutments are to be sent to a GeoMedi Co. Ltd. validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Geo Abutment from GeoMedi Co., Ltd. a line of titanium base abutments (identified as Multibase) and machinable blank abutments (identified as CMFit) to interface with compatible dental implants from four (4) manufacturers, and a total of seven (7) implant-abutment connections. The compatible implant body diameters range from 3.0 mm to 8.0 mm. The subject device prosthetic platform diameters range from 4.0 mm to 4.6 mm. All patient-specific abutments prepared from subject device Geo Abutment are to be manufactured at a GeoMedi validated milling center. Geo Multibase abutments are two-piece abutments in which the Geo Multibase Abutment comprises the first part of the two-piece abutment and a patient-specific zirconia superstructure comprises the second part; the assembly becoming a final finished medical device after cementation of the superstructure on the subject device abutment. They are provided in straight designs, and two (2) connection types: for single unit prostheses (engaging connection) and for bridge or multi-unit prostheses (non-engaging connection). They are not intended for angulation correction, as the design parameters for the superstructure are restricted to straight abutments only. These abutments are made of titanium alloy (Ti-6Al-4V) with a titanium nitride (TiN) coating on the coronal portion of the external surface, not including the implant-abutment interface. The Geo Multibase abutment and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory or separately, for the clinician to bond together chairside, using the cement required in the labeling (3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP). All patient-specific custom zirconia superstructure fabrication is by prescription on the order of the clinician. The design parameters for zirconia superstructures to be used with Geo Multibase abutments are: - Minimum wall thickness – 0.5 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 of the superstructure – 0 mm (Geo Multibase abutments have minimum gingival height of 1.0 mm) - Maximum gingival height – 5.0 mm - Maximum angle – 0° (straight only) All zirconia copings (superstructures) for use with the subject device Geo Multibase abutment will be made at a GeoMedi Co., Ltd. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Geo CMFit abutments are cylindrical titanium alloy abutments designed to be used for fabrication of a one-piece, all titanium patient-specific abutment by a CAD/CAM process. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. Geo CMFit abutments are available in engaging and non-engaging connections. All patient-specific abutment fabrication is by prescription on the order of the clinician. The design parameters for all CMFit patient-specific abutments are: - Minimum wall thickness – 0.65 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 – 5.0 mm - Maximum angle – 30° Manufacture of the Geo Abutment CMFIT patient-specific abutment is to be performed at an GeoMedi Co., Ltd. validated milling center.

Dynamic TiBase abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. Compatible Implant Systems: | Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform, mm | |---------------------------------------|---------------------------|---------------------| | Osstem® TS Hiossen® ET (Internal Taper) | 3.5 | Mini | | | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | | Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM | | Nobel Active (Conical Connection) | 3.5 | NP | | | 4.3, 5.0 | RP | | | 5.5 | WP | | Straumann Bone Level (CrossFit® Morse Taper) | 3.3 | NC | | | 4.1, 4.8 | RC | | Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB | | | 5.0, 5.5, 6.5 | WB | All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium Medical validated milling center for manufacture.

Dynamic TiBase abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. All subject device bases are made of titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively. For each of the compatible OEM implant lines, the prefabricated titanium base components are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 4 mm, and a platform diameter ranging from 4.30 mm to 5.50 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. All Dynamic TiBase prefabricated titanium base components have a post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The post height of the prefabricated titanium base component ranges from 3.8 mm to 5.40 mm, and from 2.3 mm to 3.8 mm (cut-out height). The cementable post height of the final patient-matched abutment design, measured above the total combined gingival collar, shall be no less than 4 mm. All zirconia superstructures (copings) used to complete the final two-piece subject device Dynamic TiBase abutment will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. The design parameters for the CAD-CAM zirconia superstructure for the Dynamic TiBase vary slightly among the compatible OEM implants. The design parameters for the CAD-CAM zirconia superstructure are summarized in the following table: | Implant Compatibility (1) | Minimum Wall Thickness, mm | Maximum Gingival Height, mm | Minimum Gingival Height (2), mm | Maximum Angulation | |---------------------------|---------------------------|----------------------------|--------------------------------|-------------------| | Osstem® TS Hiossen® ET (Internal Taper) | 0.32 | 5.18 | 1.2 | 25º | | Neodent GM (Morse taper) | 0.32 | 5.20 | 1.2 | 30º | | Nobel Active (Conical Connection) | 0.35 | 6.20 | 0.30 | 0º | | Straumann Bone Level (CrossFit® Morse Taper) | 0.32 | 5.18 | 1.1 | 30º | | Straumann BLX (TorcFit™ Internal Hexalobular) | 0.32 | 5.34 | 1.5 | 30º | (1) for the compatible sizes shown in Table 1 (2) minimum gingival height in the titanium base, not the zirconia superstructure The required cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is Nova Resin Cement cleared in K213609. Also, the subject of this submission are seven (7) abutment screws for use with the subject abutments.

**Custom Abutment AS Ti:** The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center. **ASC Screw:** The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

This premarket notification includes new digital abutments to the Neodent Implant System (GM, NGM and HS prosthetic interfaces). The abutments proposed on this submission are identical to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above, being the only difference between them the introduction of a new angled channel solution. This submission intends to expand the portfolio of Neodent Implant System. The Custom Abutments AS Ti are composed of a unique body with two different regions: the upper region, which is the customizable portion, and the end region presents the prosthetic interface that fits with the implant, which does not allow customization. They must be sent to a Straumann Validated Milling

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 Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 and K240982 to allow additional options of zirconia material, scanners, CAM software, and milling machines to the digital dentistry workflow. The subject devices are to be sent to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. There are no changes to the abutment design, implant compatibilities, or design parameters. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows (also referred to as point of care) under K221301 and K240982. The subject device DESS Dental Smart Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant. Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment. All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine and associated tooling and accessories. The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed CAD/CAM customizations for Preat Abutments are intended to be sent to a Preat validated Milling Center for manufacture or to be designed and manufactured according to a validated digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, milling machine and associated tooling and accessories. Preat Abutments are compatible with the following third-party implant restorative platforms: | Compatible Third-Party Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) | |---|---|---| | 3i OSSEOTITE® Certain® | 3.25 | 3.4 | | | 4.0 | 4.1 | | | 5.0 | 5.0 | | | 6.0 | 6.0 | | Astra Tech OsseoSpeed™ | 3.0 | 3.0 | | | 3.5, 4.0 | 3.5/4.0 | | | 4.5, 5.0 | 4.5/5.0 | | Astra Tech OsseoSpeed™ Plus (OsseoSpeed™ EV) | 3.0 (3.0S) | 3.0 | | | 3.6 (3.6S) | 3.6 | | | 4.2 (4.2C, 4.2S) | 4.2 | | | 4.8 (4.8C, 4.8S) | 4.8 | | | 5.4 (5.4S) | 5.4 | | BioHorizons® Tapered Internal | 3.0 | 3.0 | | | 3.5 | 3.5 | | | 4.0 | 4.5 | | HIOSSEN ET III | 3.5 | Mini | | | 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | | Implant Direct Legacy | 3.2 | 3.0 | | | 3.7, 4.2 | 3.5 | | | 4.7, 5.2 | 4.5 | | | 5.7, 7.0 | 5.7 | | Keystone PrimaConnex™ | 3.5 | 3.5 (SD) | | | 4.1 | 4.1 (RD) | | | 5.0 | 5.0 (WD) | | MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | | Neodent® GM™ Helix | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | 3.0 | | Neoss | 3.5, 4.0, 4.5, 5.0, 5.5 | 4.1 | | Nobel Biocare™ NobelActive® | 3.0 | 3.0 | | | 3.5 | NP | | | 4.3, 5.0 | RP | | Nobel Biocare™ NobelReplace® | 3.5 | NP | | | 4.0, 4.3, 5.0 | RP | | | 5.0 | WP | | | 6.0 | 6.0 | | Straumann™ BLX | 3.75, 4.0, 4.5 (RB) | RB | | | 5.0, 5.5, 6.5 (WB) | WB | | Straumann® Bone Level | 3.3 | NC | | | 4.1, 4.8 | RC | | Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN | | | 4.8, 6.5 | WN | | Zimmer Screw-Vent®/ Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 | | | 4.7 | 4.5 | | | 6.0 | 5.7 |

The purpose of this submission is to expand the use of Preat Abutments, specifically the titanium blank abutment design, to be used in a validated equipment CAD/CAM workflow where specific abutment design software, milling machines and tooling have been validated to work with the previously cleared components in K220823 and K183518. This submission includes a titanium blank design which is compatible with sixteen (16) implant system, with a distinct connection platform, as well as varying implant diameters and implant platform diameters, for each system. The Subject device abutments may be placed in implants located in the mandibular or maxillary arches. The Subject device abutments are compatible with implant body diameters that range from 3.0 mm to 7.0 mm and implant platform diameters which range from 2.9 to 6.0 mm. All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile to the end user. The design parameters for the CAD/CAM Titanium Blank custom abutment are: - Minimum wall thickness – 0.5 mm to 0.9 mm (varies by implant line); - Minimum post height for single-unit restorations (length above the abutment collar / gingival height)– 4.0 mm; - Maximum Angle – 30°*; and - Minimum gingival height – 0.5 mm; - Maximum gingival height – 1.5 mm to 4.5 mm (varies by implant line). *Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) compatible are limited to 0° maximum correction angle. The minimum and maximum abutment design parameters listed above correspond to the abutment designs used in the mechanical testing data provided in the sponsor's K220823 and K183518 device submissions. All digitally designed CAD/CAM customizations for Preat Abutments are intended to be sent to a Preat validated Milling Center for manufacture or to be designed and manufactured according to a validated digital dentistry workflow which includes: Scan files from Intra-Oral and Desktop Scanners, CAD software, CAM software, a Milling machine and associated tooling and accessories.

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

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

The Dentsply Sirona Titanium Bases system is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. For AT EV 3.0 S, AT TX 3.0 S, BH 3.0 S, and SB L 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system comprises three parts: - Abutment Block material (CEREC Cercon 4D Abutment Block) - Titanium Base (TiBase) - CAD/CAM system The TiBase is recommended for use with two-piece hybrid abutments and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The proposed Dentsply Sirona Titanium Bases system are connected to Dentsply Sirona or third-party dental implants to facilitate the prosthetic dental restoration of edentulous areas of the oral anatomy. The proposed TiBase components are assembled (through extraoral cement bonding) with the patient specific CEREC Cercon 4D Abutment Block (K234018), to form the complete, two-piece CAD/CAM Titanium Base system abutments. The bottom half of the abutment is the TiBase component, which interfaces with the implant system-specific geometry, while the top half of the abutment is the abutment block material that is milled to form either an abutment crown or a meso-structure (the latter is subsequently finished with a crown). The TiBase component therefore serves as the "platform" on which the customized milled abutment crown or the meso-structure is bonded to, forming the complete CAD/CAM Titanium Base system abutment. The completed CAD/CAM Titanium Base system abutment is attached to the dental implant with an abutment screw. The TiBase system is part of a workflow that includes CAD/CAM software cleared in predicate device, K193408, CAD/CAM system with CEREC Chairside Software, and reference device, K200191, CAD/CAM System with inLab Software, and the abutment crown and meso-structure material cleared in reference device, K234018. The TiBase components are made of the same material as the predicate device (K193408) TiBases, which is titanium alloy Ti6Al4V, complying with ASTM F136-13. While the lower part connects to the implant system, the upper part consists of a tapered, cylindrical center post which is designed to receive the abutment crown or meso-structure to complete the finished CAD/CAM abutment. The TiBase components come in small and large sizes depending on the diameter size of the connecting implant. A notch feature on the cylindrical part of the upper portion (i.e. rotational reference and lock) ensures that there is only one position to mount either a scanbody or the abutment crown/meso-structure. The TiBase component center post includes a through-channel through which a corresponding abutment screw is inserted to allow retention of the finished abutment to the implant. The abutment screw, made of the same Titanium material, when assembled with the proposed TiBase component, is located in the internal geometry of the titanium base and does not seat in the finalized abutment crown/meso-structure. The minimum/maximum design specification limits are as follows: - Maximum angulation for the Zirconia top-half material: 20˚ - Minimum wall thickness of the Zirconia top-half material: 0.5 mm - Gingival heights of the TiBase component: 1, 2, 3 mm - TiBase component post height (i.e., length above the gingival height): ≥ 4 mm

PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, and Titanium base ASC Flex are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Abutment-level prosthetic components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are intended for use as a support for multi-unit screw-retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient. All digitally designed abutments for use with PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, Titanium base ASC Flex, Multi-unit Titanium Base, Multi-unit Titanium Cap, and MedentiBASE Titanium Base are intended to be sent to an FDA-registered Medentika validated milling center for manufacture or to be manufactured according to the digital dentistry workflow, which integrates multiple components: Scans from desktop and intra oral scanners, CAD and CAM software and milling machine with associated accessories. Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The subject devices are Medentika CAD/CAM Abutments, which primarily expand the options for fabricating patient-specific final abutments from a "validated milling center" to a "digital dentistry workflow". This workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machines, and associated tooling and accessories. The devices include Titanium Base abutments, Titanium base ASC Flex abutments, and PreFace and TI-Form (blanks) abutments. The abutments are made of titanium alloy (Ti-6Al-4V ELI). Titanium base abutments also include a zirconia superstructure. The specified zirconia materials for milling superstructures are Ivoclar Vivadent IPS e.max ZirCAD Prime, Ivoclar Vivadent IPS e.max ZirCAD Prime Esthetic, Amann Girrbach Zolid Bion, Amann Girrbach Zolid Gen-X, and Institut Straumann AG n!ce Zirkonia HT. The specified cement for bonding superstructures is Multilink Hybrid Abutment Cement from Ivoclar Vivadent AG. Key design parameters for CAD/CAM zirconia superstructures (on Titanium base and Titanium base ASC Flex) include: minimum wall thickness of 0.5 mm, minimum cementable post height of 4.0 mm for single unit restorations, maximum gingival margin height of 5.0 mm, minimum gingival margin height of 0.5 mm, and maximum angulation of the final abutment of 30°. PreFace and TI-Forms abutments (blanks) are used by dental laboratories to fabricate customized abutments from titanium alloy. Their design parameters include: minimum wall thickness of 0.4 mm, minimum cementable post height of 4.0 mm, maximum gingival margin height of 5.0 mm, minimum gingival margin height of 0.5 mm, and maximum angulation of 30°. Prosthetic-level components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are provided for use with previously cleared Medentika multi-unit abutments and MedentiBASE abutments. All abutments are provided non-sterile with appropriate abutment screws. The screws attach the abutment to the implant or the prosthesis to the abutment.