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The Hex-Lock Temporary Abutment is designated for use on the internal hexagon implant interface for less than twenty-eight days usage which is placed in the edentulous mandibles or maxillae, for fixation of a final crown. The intended use of the Hex-Lock Temporary Abutment is identical to the intended use of the predicate device, the ProTect abutment from Friadent. The plastic temporary abutment is intended to be used to create an esthetic emergence through the gingiva between implant uncovering and final restoration with screw-retained or cemented restorations. Use of the plastic abutment is not to exceed twenty-eight (28) days. If time between placement of temporary abutment and final restoration needs to exceed twenty-eight (28) days then the use of a titanium abutment, which is indicated for longer-term use, is required. The abutment can be used for either a single tooth or multiple tooth unit provisional restoration and can be modified in height to suit individual needs during the fabrication of the provisional prosthesis. The plastic temporary abutment can be used to create esthetic, screw-retained or cemented provisional restorations at second stage uncovering. Once the restoration has been applied to the temporary abutment, it can be used to develop a more esthetic emergence profile. Temporary abutment is not to be used as a permanent abutment. Not to exceed 28-days of placement.

The Hex-Lock Temporary Abutment is available in 4.5mm, 5.5mm, and 6.5mm outer diameter lengths for the internal hexagon interface. The abutment/implant platform diameter is 3.5mm, 4.5mm, and 5.7mm for the internal hexagon interface. All the abutments exhibit the internal hexagon interface. The Hex-Lock Temporary Abutment is a new abutment design that is being submitted to interact with an internal hexagon dental implant system. The abutment features an internal hex engaging plastic cylinder with retentive parallel walls and a flared cuff used for short term restorations less than twenty-eight (28) days. This abutment will attach directly to the implant with a retaining screw with a long shaft that protrudes from the top of the abutment to facilitate the fabrication of the provisional prosthesis. Both screws allow for length reduction for custom height restorations. The abutment will exhibit the internal hex engaging feature. The abutment/implant interface remains unchanged.

The intended use of the Sulzer Dental Ceramic System-HexLock is for anterior single unit restoration cases. This system is intended to improve esthetics in anterior cases by replacing the metal substructure within a restoration with a tooth color ceramic structure.

The Ceramic System-HexLock uses a titanium hex core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is cemented to the core for a final restoration. The core will be offered in two implant interface diameters, 3.5mm, and 4.5mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.

The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. This product should not be used in the molars and should not be splinted together for multiple unit cases. partials or bridgework.

The Ceramic System-Spline uses a titanium Spline core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is comented to the core for a final restoration. The core will be offered in three implant interface diameters, 3.25mm, 4.0mm, and 5.0mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.

The Spline Twist implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. In patients with an edentulous mandible, Spline Twist implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

Spline Twist implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.

The ScrewVent and Tapered ScrewVent implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete In countilious of partially or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. In patients with an edentulous mandible, ScrewVent and Tapered ScrewVent implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

ScrewVent and Tapered ScrewVent implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.

Sulzer Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. The 3.15mm implant is recommended for use in the maxillary laterals for replacement of teeth in narrow interproximal areas and narrow ridges.

Spline Twist implants are available with a roughened surface or a selectively Spince Twise Internally in a 3.15mm diameter and lengths of 10, 11.5, 13, 15, and 18mm. All implants have a Spline anti-rotational feature and are fabricated from titanium alloy. The implants are all provided sterile.