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Geo Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit cement-retained prosthesis in the mandible or maxilla. Geo Abutments are compatible with the following implants. All digitally designed custom abutments for use with Geo Abutments are to be sent to a GeoMedi Co. Ltd. validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Geo Abutment from GeoMedi Co., Ltd. a line of titanium base abutments (identified as Multibase) and machinable blank abutments (identified as CMFit) to interface with compatible dental implants from four (4) manufacturers, and a total of seven (7) implant-abutment connections. The compatible implant body diameters range from 3.0 mm to 8.0 mm. The subject device prosthetic platform diameters range from 4.0 mm to 4.6 mm. All patient-specific abutments prepared from subject device Geo Abutment are to be manufactured at a GeoMedi validated milling center. Geo Multibase abutments are two-piece abutments in which the Geo Multibase Abutment comprises the first part of the two-piece abutment and a patient-specific zirconia superstructure comprises the second part; the assembly becoming a final finished medical device after cementation of the superstructure on the subject device abutment. They are provided in straight designs, and two (2) connection types: for single unit prostheses (engaging connection) and for bridge or multi-unit prostheses (non-engaging connection). They are not intended for angulation correction, as the design parameters for the superstructure are restricted to straight abutments only. These abutments are made of titanium alloy (Ti-6Al-4V) with a titanium nitride (TiN) coating on the coronal portion of the external surface, not including the implant-abutment interface. The Geo Multibase abutment and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory or separately, for the clinician to bond together chairside, using the cement required in the labeling (3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP). All patient-specific custom zirconia superstructure fabrication is by prescription on the order of the clinician. The design parameters for zirconia superstructures to be used with Geo Multibase abutments are: - Minimum wall thickness – 0.5 mm - Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin) - Minimum gingival height of the superstructure – 0 mm (Geo Multibase abutments have minimum gingival height of 1.0 mm) - Maximum gingival height – 5.0 mm - Maximum angle – 0° (straight only) All zirconia copings (superstructures) for use with the subject device Geo Multibase abutment will be made at a GeoMedi Co., Ltd. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Geo CMFit abutments are cylindrical titanium alloy abutments designed to be used for fabrication of a one-piece, all titanium patient-specific abutment by a CAD/CAM process. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. Geo CMFit abutments are available in engaging and non-engaging connections. All patient-specific abutment fabrication is by prescription on the order of the clinician. The design parameters for all CMFit patient-specific abutments are: - Minimum wall thickness – 0.65 mm - Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin) - Minimum gingival height – 0.5 mm - Maximum gingival height – 5.0 mm - Maximum angle – 30° Manufacture of the Geo Abutment CMFIT patient-specific abutment is to be performed at an GeoMedi Co., Ltd. validated milling center.