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AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are dental prosthetics placed onto a dental implant or screw retained abutment, to provide support for dental prosthetic restorations. The Base Abutments and Adhesive Sleeves include: Titanium bases/sleeves with a pre-machined implant connection or screw retained abutment connection on which the CAD/CAM designed upper structure may be fitted to complete a two-piece dental abutment. The Base Abutments and Adhesive Sleeves include an abutment/sleeve screw for fixation to the underlying implant/screw retained abutment. These dental prosthetics may be used for single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with AB Dental Implants with internal connection and screw retained connections for standard and narrow platforms. All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.

A.B. Dental Devices® CADCAM Products consists of; Base Abutments and Adhesive Sleeves which are used with Standard Platform (Internal Hex connection) implants, Narrow Platform implants and Screw retained (P64 and P14/P16 MultiUnit) abutments. Base Abutments (standard or narrow platform) and Adhesive Sleeves (screw retained abutment platform) are prefabricated abutments/sleeves made to be used as final abutments/ sleeves that will be used as adhesive connection (cement retained) of the prosthetic restoration on implant platform or on Multiunit platforms. The design and manufacturing of the patient-specific abutments take consideration the shape of the final prosthesis based on the patient's intra-oral scanning using the manufacturing. All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture. This submission adds the following Base Abutments and Adhesive sleeves: Ti Base Anti-Rotational Abutments (Standard or Narrow platforms) - Base Abutment Ti Base Rotational Abutments (Standard or Narrow platforms) - Base Abutment P64 Ti Conical Adhesive Sleeve - Adhesive Sleeve Ti Straight Adhesive Sleeves - Adhesive Sleeve Base Abutments; The titanium bases are used as part of a two-piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment. Raw material Zirconium blanks Dental Direkt Zirconia Blanks by Dental Direkt GmbH, cleared under K183569 Dental Cement PANAVIA SA Cement Universal by Kuraray Noritake Dental Inc., cleared under K183537 Adhesive Sleeves The adhesive sleeves are all Rotational (non-engage) for bridges restoration. The adhesive sleeves are made of Titanium alloy (Ti-6Al-4V ELI) and will be installed on straight or angular screw-retained abutments. The Multiunit (screw retained abutments already cleared devices) are P14/P16 platform: The below listed devices are previously cleared items that the sleeves are intended to be used with: P14-3,17-1, P14-3,17-3, P14-3,30-1, P14-3,30-3, P14-3.75,17-1, P14-3.75,17-3, P14-3.75,30-1, P14-3.75,30-3, P16-3.75,1, P16-3.75,2, P16-3.75,3, P16-3.75,4, P16-3.75,5, P64-3,1, P64-3,17-0.5, P64-3,17-2, P64-3,2, P64-3,3, P64-3,30-0.5, P64-3,30-2, P64-3.75,1, P64-3.75,2, P64-3.75,3, P64-3.75,4, P64-3.75,5, P64-3.75,17-0.5, P64-3.75,17-2, P64-3.75,17-3, P64-3.75,30-0.5, P64-3.75,30-2, P64-3.75.30-3

A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

A.B. DENTAL DEVICES® Dental Implants System consists of narrow (XXX-3 model number) and standard (XXX-3.75 model number) platform internal hex implants that are used with screw retained, cement retained, or overdenture abutments. This submission adds the following abutments: - Expansion of the P4 angled abutments to include: . - Narrow platform abutments (standard and long lengths, 15 and 25 degrees) o - Narrow platform, anatomic abutments (15 degrees) o - o Additional standard platform abutments (15 and 25 degrees) - Additional standard platform, anatomic abutments (15 and 25 degrees) O - . Expansion of the P5 ball attachments to include narrow platform, 20 degree abutments - Expansion of the P14 multiunit, angled abutments to include: - Additional sleeve materials (Delrin and CoCr) O - Narrow platform abutments (17 and 30 degrees) O - P25 AB LOC for angular adaptor O - Addition of P64 multiunit, straight and angled product line (narrow and standard platform, 17 ● and 30 degrees, with Delrin and Ti alloy sleeves), including its healing cap. - . Modification to the P4a-S screw to improve its performance characteristics