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Solidex® Ti-Links and Screws is 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 Solidex® Ti-Links is to be sent to a CREODENT HUDSON VALLEY 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.

Solidex® Ti-Links & Screws consists of a two-piece abutment, where the titanium base will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a Solidex® Screw for fixation to the implant body. Solidex® Ti-Link are made of titanium alloy conforming to ASTM F136 standard specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters. Solidex® Screw is composed of titanium alloy per ASTM F136.

Solidex® Ti-Links & Screws is designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. There are two-piece abutments for which the second part (or top half) is the zirconia superstructure. They also may be used for support of a crown directly on the Ti-Link. CAD/CAM zirconia superstructure fabrication for Ti-Link is by prescription on the order of the clinician.

Solidex® Ti-Links & Screws all zirconia superstructures for use with the subject device Ti-Link will be manufactured using a digital dentistry workflow, either at a Validated Milling Center (VMC) or at the Point of Care (POC), by using scan files from intra-oral and lab (desktop) scanners, CAD/CAM software, ceramic material, and associated tooling and accessories. The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD/CAM software, ceramic material, and associated tooling and accessories. The digital workflow includes the following products:

• Ceramic material: Sagemax NexxZr T (K130991)

• Cement: Panavia SA cement Universal (K183537)

• Desktop scanner: 3Shape E series Lab Scanner (510(k) exempt under 21 CFR 872.3661)

• Design software: 3Shape Abutment Designer Software (K151455)

• Milling machine: PrograMill PM7 (510(k) exempt under 21 CFR 872.3661)

• Milling software: PrograMill CAM (510(k) exempt under 21 CFR 872.3661)

• Digital Library / Templates (3 Shape): The Solidex® Ti-Link CAD/CAM System shall only be used with the official "Solidex® Ti-Link Digital Library" and templates identified. The library is imported into the 3Shape software, and the design restriction parameters (minimum wall thickness, post height, maximum gingival height, etc.) are automatically applied. The official "Solidex® Ti-Link Digital Library" can be obtained from CREODENT HUDSON VALLEY by contacting support email (inquiry@creodental.com) or from CREODENT HUDSON VALLEY web-site.

When imported into the 3Shape software, the design restriction parameters (minimum wall thickness, post height, maximum gingival height, etc.) and built-in protection features ("stops" and restriction shells) are automatically applied.

The design parameters for the CAD/CAM zirconia superstructure to be used Solidex® Ti-Links & Screws:

• Minimum wall thickness: 0.5 mm
• Minimum abutment post height: 6.0 mm
  (Note)
  : The abutment post height is the dimension above the gingival height.
  : Feature maximum abutment post height are based on patient anatomy and clinician discretion.
• Minimum gingival height: 0.5 mm
• Maximum gingival height: 6.0 mm
• Minimum Angulation: 0°
• Maximum Angulation: 20°

The zirconia superstructure must be cemented to the Solidex® Ti-Links using Panavia SA cement Universal in a dental laboratory. Solidex® Ti-Links & Screws is provided non-sterile therefore must be sterilized after the cementation of the zirconia superstructure on Solidex® Ti-Links. Solidex® Screws are designed to attach the abutment to the implant.

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The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.

The EK Multi Angled 30 Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized. The EK Multi Angled 30 Abutments are available in various lengths and diameters.

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Multi-Unit DAS System is intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

Compatible Implant Systems

All digitally designed custom abutments for use with Multi-Unit DAS System are to be sent to a Talladium validated milling center for manufacture.

Multi-Unit DAS System 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

Multi-Unit DAS system abutments are designed for retention of multi-unit or single-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For all compatible OEM implant lines, the multi-unit abutment components are provided with gingival heights ranging from 1 mm to 4 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm.

This submission includes one (1) abutment level Ti-Base (coping) Engaging Interface for use with the subject multi-unit abutments. The subject Ti-Base (coping) Engaging Interface is a straight prepable design with an additional gingival height of 1.5 mm and a prepable 10.5 mm prosthetic post. This Ti-Base (coping) Engaging Interface has an engaging interface to the multi-unit abutments and is to be used to fabricate a straight final abutment and a straight final restoration. The subject device is identical to the previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559), except the current subject device has an engaging interface. The previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559) is to be used to fabricate a straight final abutment and a straight final restoration.

The subject device multi-unit abutments may be used with the following components, all previously cleared in K231559: Straight Ti-base, non-engaging, part number 35.312.209.21-2; DAS Multi-Unit Engaging Dynamic Ti-Base, part number 31.312.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.21-2; DAS Multi-Unit Healing Cap Regular, part number 40.320.003.88-2; DAS Multi-Unit Healing Cap Wide, part number 40.320.003.89-2; DAS Multi-Unit Dynamic Screw 3.0, part number 41.320.040.01-2; DAS Multi-Unit Provisional Dynamic Screw, part number 41.320.050.02-2; and DAS Multi-Unit Straight Screw, part number 40.320.003.06-2.

No new DAS Multi-Unit Dynamic Ti-Bases are included in this submission. The previously cleared DAS Multi-Unit Dynamic Ti-Base (coping) components (K231599), part numbers 31.312.209.01-2, 31.322.209.01-2, and 31.322.209.21-2 may be used with the subject device Angled Multi-Unit abutments to fabricate a final angled abutment.

A summary of the subject device Multi-Unit DAS System abutment compatibilities with the OEM implants is provided in the following Table 1 Summary of Compatibilities.

Table 1 Summary of Compatibilities

All zirconia superstructures for use with the subject device Multi-Unit DAS system 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 subject Multi-Unit DAS Dynamic Ti-base are:

• Minimum wall thickness – 0.25 mm
• Minimum post height for single-unit restorations – 4.0 mm
  (post height measured above the gingival height of the final patient-matched design)
• Maximum gingival height – 4.90 mm
• Minimum gingival height – 3.89 mm
• Maximum angulation – 15°

The design parameters for the CAD-CAM zirconia superstructure for the subject device Multi-Unit DAS Ti-Base (coping) Engaging Interface are:

• Minimum wall thickness – 0.25 mm
• Minimum post height for single-unit restorations – 4.0 mm
  (post height measured above the gingival height of the final patient-matched design)
• Maximum gingival height – 4.90 mm
• Minimum gingival height – 3.89 mm
• Maximum angulation – 0°

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The Straumann Variobase Abutments XC for Bridge/Bar are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase Abutments XC for Bridge/Bar are indicated for screw-retained or cement-retained bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and shape the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed in occlusion when the implant is fully osseointegrated.

Straumann Variobase Abutments XC for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations.

The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

The subject Variobase abutments are manufactured from Ti-6Al-7Nb (TAN) and are anodized in violet.

The Variobase Abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations.

The Variobase abutments are provided non-sterile with instructions for end user steam sterilization. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from Ti-6Al-7Nb (TAN). The subject Straumann Variobase Abutments XC for Bridge/Bar is provided in two different platform models, both available with straight and angled screw channel solutions:

Table 10.4.a - Straumann Variobase Abutments XC for Bridge/Bar characteristics

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IPDmilled Blanks 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 CAD/CAM customizations for the IPDmilled Blanks are to be designed and manufactured according to digital dentistry workflow or to be sent to an IPD validated milling center for manufacture. 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. Compatible Implant Systems: Dentium Co., Ltd Implantium, Friadent Implant Systems, Neoss ProActive Implant, SPI® Dental Implant, Inicell®, BEGO Semados® S-Line, ANKYLOS® C/X Implant System, MIS V3 Conical Connection Dental Implant System, Conical Connection Implants (MIS® C1), MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments, PRAMA White Implant Systems, Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants, Straumann TLX Implant System, Kontact Dental Implant System, ICX-Implant System, Tapered Pro Conical Implant System, Straumann® Tissue Level, Zimmer Tapered Screw-Vent®, Nobel Biocare® Nobel Active®, Straumann® Bone Level Tapered Implants, Neodent Implant System – GM Line, Osstem Implant System, Xpeed AnyRidge Internal Implant System, 3i Osseotite® Certain® Dental Implants, Astra Tech Implant System (Osseospeed®), OsseoSpeed™ Plus, BioHorizons Tapered Internal Implant System, MIS Internal Hex Dental Implant System (MIS® Seven®), Straumann BLX Ø3.5 mm Implants, Straumann® BLX Implant System, ALTATEC Camlog Screwline Implant System, Replace TiUnite Endosseous Implant.

The purpose of this submission is to expand abutment categories of IPD Dental Implant Abutments, which were previously cleared.

IPDmilled Blanks is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPDmilled Blanks have a pre-manufactured connection interface that fits directly with a pre-specified dental implant. The customized shape of the abutment is intended to be designed and manufactured according to a digital dentistry workflow or to be sent to an IPD validated milling center for manufacture. IPDmilled Blank is delivered non-sterile and the final restoration, including the screw, is intended to be sterilized at the dental clinic before it is placed in the patient.

The IPDmilled Blanks are blistered together with their specific screw. The screws are intended to attach the prosthesis to the dental implant.

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

The design and manufacturing of the custom abutment will be conducted using a digital dentistry workflow requiring the use of the following equipment and software:
Intraoral Scanner: 3Shape TRIOS A/S Series
Desktop Scanner: 3Shape E Series.
Design Software: 3Shape Abutment Designer Software, K151455.
AbutmentCAD, K193352.
Milling unit: CORiTEC 350i PRO / CORiTEC 350i Loader PRO with MillBox CAM software.

IPDmilled Blank libraries' have built-in design limitations, and the user isn't allowed to exceed these limitations. The custom abutment design limitation specifications are as follows:
Minimum gingival height: 0.5 mm
Maximum gingival height: 6.0 mm
Minimum wall thickness: 0.4 mm
Minimum post height: 4.0 mm

All IPDmilled Blanks are for straight abutments only.

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Medentika Custom Abutments AS (Angulated Screw Channel) 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. Medentika Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS.

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, and Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The Custom Abutments (previously named MedentiCAD and PreFace abutments) can be used in combination with cemented prosthetics, e.g., crowns and superstructures, to reconstruct the function and esthetics of lost teeth. The Custom Abutment is a one-piece abutment, which is a customized abutment that is digitally designed by the customer with Straumann® CARES® Visual and can be only milled and ordered from the Straumann validated milling center. The abutments have an implant-specific connection interface for the respective compatible implant. The previously cleared Custom Abutments feature a straight screw channel for the abutment screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments AS (Angulated Screw Channel) to the Medentika Custom Abutment Portfolio. The subject Medentika Custom Abutments AS can be designed and manufactured with an angled screw channel (as opposed to the predicate straight screw-channel), so that the screw-exit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angulated to allow screwdriver access at an angle up to 25°.

Each of the abutment to implant connection geometries (in terms of Series and implant diameter) currently exists for the existing marketed Medentika Custom Abutments (with straight screw channel). No new compatible implant is added, in terms of series, implant diameter, and implant platform diameter within this submission.

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The DIMPLO Implant System is intended for use in the maxilla or mandible of partially or fully edentulous patients to support single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, as well as terminal or intermediate abutment support for fixed bridgework. It is intended for two-stage surgical procedures and may be used for immediate loading when good primary stability and appropriate occlusal loading conditions are achieved.

• Ø3.3 mm implants are for replacing maxillary lateral incisors and mandibular incisors with delayed loading only.
• Ø5.0 mm and larger implants are intended for delayed loading in the molar region.

All digitally designed custom components (including Ti-Base and Pre-milled Blanks) for use with the DIMPLO Implant System are to be manufactured at a DIMPLO validated milling center.

The DIMPLO Implant System consists of fixtures, abutments, and attachments designed for dental implant procedures.

Fixture: Made of unalloyed titanium (Grade 4, ASTM F67), these dental implants are available in a range of diameters and lengths to accommodate various clinical applications in the maxilla and mandible. The surface is treated with SLA (Sandblasted, Large grit, and Acid-etched) and provided sterile via gamma irradiation. Available in two platform sizes: Mini and Regular.

Abutment: These components aid in prosthetic restorations. This category includes Cover Screws, Healing Abutments, Temporary Abutments, Cemented Abutments, Angled Abutments, Ti-Base, Pre-milled Blanks, Screws, Multi-unit Abutments, Healing Caps, and Cylinders.

Attachments: Includes Locatus Male Cap and Locatus Retention Male. The Locatus Male Cap is made of titanium alloy (Ti-6Al-4V ELI), while the Locatus Retention Male is made of nylon.

Fixtures and cover screws are supplied sterile. All other abutments and attachments are provided non-sterile and must be sterilized by the end user before use.

Ti-Base consists of a two-piece abutment that includes a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient-specific superstructure) at the top, composing the final abutment.

Superstructure and Bonding Materials

• Zirconia material: InCoris Zi (ZrO₂) (K123664, Sirona Dental Systems GmbH)
• Bonding agent: RelyX Unicem 2 Automix (K100756, 3M ESPE)

Design Envelope for Zirconia superstructure

Design Envelope for Pre-milled Blank

Note: Abutment Post Height is defined as the minimum cementable post height for single-unit restoration, measured as the height above the restorative margin.

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