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Bonafix TiBase abutments are 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.

The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The dental restoration and mesostructure are fabricated using a CAD/CAM process. The subject device abutment platform diameters range from 3.0 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm to 7.0 mm. The apical end is prefabricated to match the compatible implant platform and is available with implant connections for crowns (engaging) or bridges (non-engaging). Each abutment is provided with a screw designed to match the compatible implant. The titanium base abutment and screw are manufacturated from titanium alloy conforming to ASTM F136. The superstructure is to be manufactured from zirconia conforming to ISO 13356. The subject devices are provided non-sterile to the end user. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated Milling center for manufacture. The zirconia superstructure in straight only and is not to be designed to provide an angle or divergence correction.

Bonafix 2 Plus Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Bonafix 2 Plus implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading.

The current submission requests clearance for the Class II Bonafix 2 Plus implant system. The Bonafix 2 Plus Implant is a bone level type implant, built in Grade 5 ELI Titanium Alloy and treated with RBM technology. The implant has a conventional internal hex connection style. The crestal zone of implant have micro-rings. The design crestal zone (straight or tapered) depends on Implant diameter because the implant system has only one platform. The body of the implant is tapered, designed with a double progressive thread with a small internal channel at the bottom of the thread; and the apex of the implant has a flat shape. Has two-spiral channel at the apical end of the implant that provide self-tapping properties to the implant. The implants are provided in several different dimensions, 3.5, 3.75, 4.2, 5.0, and 6.0mm of diameter, and lengths of 8, 10, 11.5, 13 and 16mm. Hex Connection 6.0 diameter implants do not come in 13 or 16mm length. Cover screw, Healing Caps (3.8 and 4.6mm of diameters) and 3 types of abutments: Straight abutments, Angled abutment and Multi-unit abutments, are included in the system.