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The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging, is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration. The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary.

The purpose of an abutment with Cast-to capabilities is to satisfy customer needs of attaching cast framework prostheses to an abutment. The nonengaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The engaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast a single abutment for a cement-retained crown or bridge and frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System is designed for use with Zimmer 3.1mmD Dental Implant System to support cast framework prostheses. The engaging abutment/implant interface is an internal conical connection with a hex. The non-engaging abutment/implant interface is a connection that sits on top of the implant but does also has cylindrical features that sit passively within the implant. The abutment is composed of Gold Alloy 6019 and secured to the implant with a separate Titanium alloy screw for retention.

Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The Zimmer 3.1mmD Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a singleor multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration. The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired. The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only. The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing. The Retaining Screws are intended to be used for securing the temporary abutments, final abutments and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.

The Zimmer 3.1mmD Dental Implant System consists of 3.1mm threaded endosseous dental implants, as well as prosthetic components, and ancillary components for placement and restoration of these implants. The prosthetic components include 2.9mm Angled Abutment, 2.9mm Angled Abutment, Straight Hex, 2.9mm Contour Abutment, 2.9mm Contour Abutment, Straight Hex , 2.9mm Temporary Abutment, and 2.9mm Ball Abutment. The 2.9mm Angled, 2.9mm Contour, and 2.9mm Temporary Abutments are made to support single or multiple unit restorations. The 2.9mm Ball Abutments are made to support overdentures. The ancillary components for the Zimmer 3.1mmD Dental Implant System include 2.9mm Healing Collars and 2.9mm Healing Screws which are used during the healing process. Zimmer 3.1mmD Dental Implant is an endosseous dental implant composed of titanium alloy. The implant body is designed for ease of implantation and with greater surface area for osseointegration. The implant surface is treated to facilitate osseointegration. In addition, the implant body is tapered with triple-lead threads. The Zimmer Dental 3.1mmD Dental Implant is currently offered in 3.1mm diameter in lengths of 8, 10, 11.5, 13, and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1: Tapered Screw-Vent Implant Dental Implant. The implant-abutment interface platform diameter will be offered in a size of 2.9mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The Abutments, Healing Collars, and Healing Screw are titanium alloy devices that are made to mate with the Zimmer 3.1mmD Dental Implant, which is also made of titanium alloy. The abutments are designed for use as a terminal or intermediate abutment prostheses.

The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform.

The Zimmer Zfx Titanium Abutment for the Biomet 3i Certain implant system is designed for use with Biomet 3i internal connection implants to support single or multi tooth restorations. The abutment/implant interface is an internal hexagonal connection. The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility. The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs. The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention. The new abutment will be offered in 3.4mm, 4.1mm, 5.0mm and 6.0mm implant platforms.

The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bone Level implants with a Narrow CrossFit Connection (NC) Ø3.3mm or Regular Crossfit Connection (RC) Ø4.1mm or Ø4.8mm.

The Zimmer Zfx Titanium Abutment for the Straumann Bone Level implant system is designed for use with Straumann Bone Level implants to support single or multi tooth restorations. The abutment/implant interface is a conical connection with 4 grooves for insertion guidance. The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility. The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs. The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention. The new abutment will be offered in Narrow CrossFit (NC) Ø 3.3mm and Regular CrossFit (RC) Ø 4.1mm or Ø 4.8mm implant connection sizes.

The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single-unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility.

The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a two piece abutment. The abutment is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment is used for single unit restorations in the anterior and posterior regions. The abutment base will be made available in 3.5, 4.5 and 5.7mm platforms. The Zimmer Zfx Titanium Base serves as a bonding base that allows for cementation of a patient-specific restoration. Copings, crowns and bridges can be used with the Zimmer Zfx Titanium Base. The Zimmer Zfx Abutment Coping is a zirconia mesostructure component that would be cemented onto the Zimmer Zfx Titanium Base Abutment to form the two-piece abutment. These componenents will be manufactured from zirconia or IPS e.Max. The maximum angulation that is allowed is 20°. The two piece abutment would then be able to be used as a terminal or intermediate abutment for cement or screw retained prostheses that is for a single or multi-unit (bridge) restoration. The Zimmer Zfx Abutment Coping would require a separate crown to be cemented onto the coping or direct veneering to be applied.

The Zimmer Zfx Titanium Abutment for NobelActive Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelActive and NobelReplace Conical Connection implants with a Narrow Platform (NP) Ø 3.5mm or Regular Platform (RP) Ø 3.9mm

The Zimmer Zfx Titanium Abutment for the NobelActive Implant system is designed for use with NobelActive and NobelReplace Conical Connection endosseous dental implants to support single or multi tooth restorations. The abutment/implant interface is an internal conical connection with a hexagonal interlock. The Zimmer Zfx Titanium Abutment for NobelActive Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility. The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs. The abutment is composed of Titanium alloy (Ti6Al4V), and is secured to the implant with a separate Titanium alloy screw for retention. The new abutments will all be available with a choice of 3.5mm and 3.9mm implant platform diameters.

The Zimmer Dental Tapered Screw-Vent®T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are a self-tapping, screw type endosseous dental implant designed for bone level placement and can be used in a single or two stage protocol. The implant is composed of titanium alloy with hydroxylapatite (HA) coating, and has a tapered body with an external triple lead thread design. Identical to predicate #1, the new device has the same implant to abutment internal hex friction-fit connection. The new device will have coronal microgrooves that extend to the collar within 0.64mm of the top of the implant identical to predicate #2. The new implant will be offered in two surface finish configurations at the coronal end: full MTX texturing to the top of the implant and partial MTX texturing to 0.5mm from the top of the implant leaving a machined collar. Both coronal configurations are identical to the currently marketed predicate #2 device (K101977, K111889). The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated family is composed of tapered implants with a choice of diameters and lengths. Both implant configurations, machined and fully textured collar, will be available in diameters of 3.7mm, 4.1mm, 4.7mm, and 6.0mm and in five lengths: 8, 10, 11.5, 13, and 16mm. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. The drilling sequences and drills that will be utilized to place the new device are pre-existing sequences and drills that are listed in the previous 510(k) K011028.

The Zimmer Trabecular Metal Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region. The 4.1mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the molar region. The 4.1mmD x 8mmL Zimmer Trabecular Metal Implant should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

Trabecular Metal Implant is an endosseous dental implant composed of titanium alloy and Trabecular Metal (tantalum). The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads. The Trabecular Metal Implant family is currently offered in 4.1. 4.7, and 6.0mm diameters in lengths of 8. 10. 11.5. 13. and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1 : Trabecular Metal Dental Implant. An additional Trabecular Metal implant with a new diameter of 3.7mmD will be offered in lengths of 10, 11.5, 13 and 16mmL. The implant-abutment interface platform diameter will be offered in a size of 3.5mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.

The Zimmer Zfx Abutment for Nobel Replace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedy abutinent our be access with a Narrow Platform (NP) Ø 3.5 mm, Regular Platform (RP) Ø 4.3 mm, Wide Platform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0 mm.

The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles. They frequently incorporate the modifications typically done at a dental laboratory or "chair-size" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, the Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility. The Zimmer Zfx Abutment for NobelReplace Implant System is a dental implant abutment with a fixed competitor compatible interface. It is designed for use with NobelReplace endosseous dental implants to support single or multi tooth restorations. The abutment-implant interface is an internal tri-lobe. The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs. The abutment is composed of Titanium alloy (Ti6AI4V) and it is secured to the implant with a separate Titanium allov screw for retention. The new abutment will be available with a choice of 3.5mm, 4.3mm, 5.0mm, and 6.0mm platform diameters. The maximum abutment anqulation will be 20°. The new abutment will interface with Nobel Replace implants with an internal tri-lobe connection.

The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, on-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system.

The Zfx Dental CAD system is software that is used to design dental restorative prosthetic devices from digital optical impressions. The software receives topographical characteristics of dental impressions or stone models from a compatible scanning system. The design created in the software is complied into a format enabling manufacturing of a patient specific component at Zimmer Dental. The CAD software is pre-installed on a Windows compatible computer system.