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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The design parameters for Ti-blanks are:

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

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