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The T3® Pro Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. The T3® Pro Implants may also utilize immediate loading for these indications. The T3® Pro Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

The T3® Pro Implants with the new ZimVie Implant Packaging System. The material and design of the subject device is identical to the primary predicate device T3® Pro Implants cleared in K213672. The ZimVie Implant Packaging System configuration, similarly to the primary predicate device, consists of a titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed in a heat-sealed outer tray, covered with a Tyvek® lid. The outer tray is placed inside a cardboard box, and gamma sterilized. The new ZimVie Packaging System has been standardized to align the packaging across all ZimVie implant families. The subject device in the new ZimVie Packaging System has a shelf-life of two (2) years.

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).

The Leone Orthodontic Implant TADs (Temporary Anchorage Devices) are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

Leone TADs are miniscrews made of titanium for surgical use (ISO 5832-3/ASTM F136). These orthodontic miniscrews are self-drilling with right-hand thread and they are available in an 8mm length. These devices are supplied sterile and sterilized by gamma irradiation.

The Bioline Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Charanga, Bolero and DACA are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Bolero 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

The Bioline Dental Implant System contains 2 designs of internal hex implants and various types of abutments as described below as well as 1 design of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user. Charanga implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Maer comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 6.0mm diameter). Bolero implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Ragil comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth. Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available. Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm. Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm. Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm. Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm. Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm. Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified. Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. Internal Hex IH Retentor Attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The IH Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm. Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm. DACA implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. DACA comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm. Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available. Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm. Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm. Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP. Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP. Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. Conical Retentor attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm. Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

MBA Biotech Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region.

The MBA Biotech Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of teeth. It is two stage endosseous screw type implant with internal hexagonal connection. This system consists of the fixture, cover screw, and various abutments. Only the subject abutments can be used with the subject fixtures. The Fixture is made of Pure Titanium of ASTM F67 and the surface of the fixture is treated with the SLA(Sand-blasted, Large grit, Acid-etched surface). Fixture is provided sterile.

CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.

The CeraRoot TL Implant System is the two-piece tissue level variant of the original ceramic dental implant one-piece CeraRoot Implant System (K093595) available since 2011 in the USA and 2006 in Europe. CeraRoot® dental implants are made of Y-TZP zirconium dioxide ceramics in accordance with ISO 13356. CeraRoot® dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The outer surface is acid etched for good osseointegration. The new TL (two-piece) variants are available in different lengths (8,10, 12 and 14mm) and only for the models CeraRoot 34TL (⌀ 5mm), CeraRoot 21TL (⌀ 5.6mm) and CeraRoot 16TL (⌀ 7mm). The implants are provided sterile in sterile packaging and are intended for single use. CeraRoot implants must not be re-sterilized or disinfected either. The CeraRoot TL abutments are made of the same Y-TZP ceramic material as the implants, and are attached to the CeraRoot TL implants by cementation. After the cementation of the abutments into the implant then the restorative prosthesis can be custom-made, produced and cemented on top to finish the treatment. The CeraRoot TL abutments are available with the lengths 4.3 and 5.8 mm. The CeraRoot TL abutments are provided non-sterile. They are intended for single use and must not be reused. Before use they must be cleaned, disinfected and sterilized according to the instructions given in the "instructions for use of CeraRoot TL abutments" document.

The OsseOne Dental Implant System implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. OsseOne Dental implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseOne Dental implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

The OsseOne Dental Implant System contains 1 design of internal hex implant and a multipurpose indexed hex abutment as described below as well as 3 designs of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from ASTM F136 Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments are intended to be modified by the user other than the multipurpose indexed abutments & tapered multipurpose abutments which can be reduced in height to a minimum of 6mm above the platform. Multipurpose indexed abutments & tapered multi-purpose abutments are not intended for angular correction and are not intended to be cast. OsseoMax Hex implants are tapered internal hex implants with evenly spaced large threads the length of the implant. OsseoMax Hex comes in 4.6, and 5.4 mm diameter with lengths of 8, 10mm. OsseoMax Hex are only restored using hex ball attachments or Denture Lock hex cleared in K182293. Tapered Multipurpose Indexed Hex Abutments have a 3.75mm platform diameter with a total height of 10.98mm. Height above the platform is 7.58mm. Tapered Multipurpose Indexed Hex Abutments are to be used with internal hex implant designs cleared in K182293 and are not to be used with OsseoMax Hex. OsseoCone implants are slightly tapered conical implants with evenly spaced sharp edge threads with microthreads in between them as well as microgrooves in the collar. OsseoCone comes in NP (3.5mm), and RP (4.3, 5.0, and 5.5mm) in lengths of 8.5, 10, 11.5, 13 and 15mm. OsseoCone Plus implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. OsseoCone Plus comes in 3.5 (NP), 4.3 (RP), 5.0 (RP) and, 5.5 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16 mm (no 5.5 x 16mm). OsseoMax Conical implants tapered conical implants with evenly spaced large threads the length of the implant. OsseoMax Conical comes in 4.6 and 5.4 RP diameter with lengths of 8, 10mm. OsseoMax Conical are only restored using Conical ball attachments or Conical Denture Lock. Conical healing caps come in NP and RP (3.75 and 4.5 mm diameter) with cuff heights (also height above gingiva) of 2,3,4,5 mm. Total heights are 7.32, 8.32, 9.32, 20.32 mm and 7.47, 8.47, 9.47, 10.47mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available. Conical straight abutments in 4.5mm diameter come in NP and RP with heights above gingiva of 7.7, 10.7 and 6.1, 8.3mm. Total heights are 11.85, 15.9mm and 10.6, 13mm. Conical anatomic abutments in 4.5mm diameter come in NP and RP with gingival heights of 1,2,3 mm. Height above the platform is 7.5mm. Total heights are 11.8, 12.6, 13.6mm for both NP and RP versions. Conical angled anatomic abutments in 5mm diameter come in 15° and 25° NP with shoulder cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm. Height above platform is 7.6mm. Conical angled anatomic abutments in 5mm diameter come in 15° and 25° RP with shoulder cuff heights of 1,2,3,4 mm and total heights of 11, 12, 13, 14 mm. Height above platform is 8.4mm. Multipurpose Indexed Conical abutment comes in NP, RP, and RP Wide with platform diameters of 4.2, 4.2 and 4.7 mm Total heights are 11.69, 11.33 and 11.33 mm. Height above platform is 8.29, 7.93, 7.93mm. Multipurpose Indexed Conical abutments are to be used with the conical implants listed above but are not to be used with OsseoMax Conical Implants. Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. Total heights are 9.5, 10.5, 11.5, 12.5, 13.5, 14.5mm and 9.45, 10.45, 11.45, 12.45, 13.45, 14.45mm. Height above the platform is 3.47, 4.47, 5.47, 6.47, 7.47, 8.47mm and 4, 5, 6, 7, 8, 9mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. The housing and retention caps were cleared in K182293. Conical Denture Lock attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. Total heights are 8.95, 9.95, 10.95, 11.95mm and 8.7, 9.7, 10.7, 11.7mm. Height above the gingiva is 2.3, 3.3, 4.3, 5.3mm. The Denture Lock attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. The housing and retention caps were cleared in K182293. Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm. Height above platform is 3.6, 4.6, 5.6, 6.6, 7.6mm. Total heights are 9.1, 10.1, 11.1, 12.1, 13.1mm and 9.25, 10.25, 11.25, 12.25, 13.25mm. Conical NP and RP Angled Multi-Units are 4.8mm in diameter and come in 17° and 30° with cuff heights of 1, or 2 mm. Cone height above platform 2.15mm. NP total heights are 6.35, 7.35mm and 6.85, 7.85mm. RP total heights are 6.75, 7.11mm and 7.15, 8.15mm. Conical abutment screws in NP & RP are used with conical abutments including angled multi-units.

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

The DAND Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Charanga, Bolero and DACA are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Bolero 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

The DAND Dental Implant System contains 2 designs of internal hex implants and various types of abutments as described below as well as 1 design of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user. Charanga implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Maer comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 6.0mm diameter). Bolero implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Ragil comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth. Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available. Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm. Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm. Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm. Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm. Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm. Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified. Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. Internal Hex IH Retentor Attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The IH Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm. Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm. DACA implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. DACA comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm. Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available. Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm. Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm. Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP. Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP. Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. Conical Retentor attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm. Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.

Atlantis® Abutment in Titanium refers to the following abutments that are the subject of this 510(k): - Atlantis® Abutment, - Atlantis® Crown Abutment, - Atlantis® Conus Abutment, and - Atlantis® Healing Abutment. The Atlantis® Abutments in Titanium are patient-specific dental abutments that are intended for attachment to dental implants in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The design of the Atlantis® Abutments in Titanium is derived from patient dental models and is completed by Dentsply Sirona using computer-assisted design (CAD) technology according to the clinician's prescription. The final CAD design of the Atlantis® Abutment in Titanium is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. Design and fabrication of the Atlantis® Abutment in Titanium is completed in internal Dentsply Sirona manufacturing facilities. Alternatively, the CAD design, according to the clinician's prescription, can be performed by a laboratory or clinician in an FDA cleared abutment design software (3Shape Abutment Designer Software, K151455) within the design envelope of the Atlantis® Abutments which is codified in the validated and locked design library of the cleared software. Fabrication of the Atlantis® Abutment is then completed in internal Dentsply Sirona manufacturing facilities. The Atlantis® Abutment in Titanium serves as a connection of the prosthetic construction and the endosseous implant. The lower part of the abutment is designed to fit with the specific implant geometry it is compatible, and the upper part design is according to the patient's specific anatomy. The Atlantis® Abutment in Titanium, including the Conus abutments and Healing abutments, are available in Titanium or Gold-shaded Titanium (titanium nitride layer applied using PVD (Physical Vapor Deposition)). The Crown Abutment is only available in Titanium. The Atlantis® Abutment design envelope became the basis for the other more specific designs that make up the Atlantis® Abutments in Titanium. The Atlantis® Abutment is intended for use with an endosseous implant and for single tooth restoration. The Atlantis® Crown Abutment in Titanium incorporates a design that is a combination of an abutment and an anatomically accurate crown to constitute the final finished device. It functions as a substructure that also serves as the final abutment, in a partially or completely edentulous patient. The Atlantis® Conus abutment supports a removable prosthesis (bridges and overdentures) which is retained by friction fit to the abutment. The abutment connects to the prosthesis via caps embedded in the prosthesis. The Atlantis® Healing Abutment is used with the compatible implants for temporary use during soft tissue healing after one-stage and two-stage surgeries. It is designed based on the planned final Atlantis® Abutment or Atlantis® Crown Abutment, using the same emergence profile as those abutments to achieve an aesthetic outcome during the soft tissue healing phase. Unless otherwise noted in this summary, the design envelope has remained unchanged from the previously cleared systems. Parameters such as gingival height and abutment diameter are dependent on the different implant system compatibilities.