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IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

IPD Dental Implant Abutments 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 svstems. IPD Dental Implant Abutments includes the following categories of dental abutment designs: -Titanium base (Interface) abutments; -Multi-unit abutments; -Overdenture abutments (PSD). The system also includes the corresponding Titanium Screws, which were included in previous premarket notifications. The devices are intended to attach the prosthesis to the dental implant. Specifically: - Ti Screw: Used during restoration fabrication. - TiN Screw: Used in finished restorations, with TiN coating. - TPA Screw: Used in finished angulated restorations, with TiN coating. 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 purpose of this submission is to expand IPD Dental Implant Abutments cleared under K240570: . To expand IPD's abutment designs (Multi-unit and Overdenture abutments), as well as to expand the range of angulations available for certain compatible Ti Bases (Interfaces). IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems: (List of compatible implant systems provided in tables). The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. Ti Base (Interface) abutments are attached (screw-retained) to the implant and cemented to the zirconia superstructure. The Ti Base is a two-piece abutment composed of the titanium component, as the bottom-half, and the zirconia superstructure, as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDA-cleared design software (3Shape Abutment Designer™ Software, cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care, or at a dental laboratory. The design and fabrication of the zirconia superstructure for Ti Base (Interface) will be conducted using a digital dentistry workflow requiring the use of the following equipment, software and materials: Scanner: 3D Scanner D850. Design Software: 3Shape Abutment Designer Software, K151455. Zirconia Material: DD Bio Z, K142987. Milling machine/Brand: Dental Concept System Model: DC1 Milling System Cement: Multilink® Automix, K123397. Ti Base (Interface) abutment design parameters for the zirconia superstructure are defined as follows: Minimum gingival height: 1.5 mm Minimum wall thickness: 0.43 mm Minimum post height for single-unit restorations: 4.75 mm (1) Maximum gingival height: 6.0 mm Maximum angulation of the final abutment 30° (2) Note 1: Post height is the length above the abutment collar. Note 2: In Table 2 it has been specifically referred to the angulation depending on the dental implant system and platform. The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient.

IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

IPD Dental Implant Abutments 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. IPD Dental Implant Abutments includes the following categories of dental abutment designs: Healing abutments; Temporary abutments; Cementing titanium abutments; Titanium base (interface) abutments; The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant.