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The Paltop Dental Implant System Internal Hex Standard and Wide Platforms implants (implant diameters 3.75 and above and lengths 8mm and above) as well as Conical Connection implants (implant diameters 3.75 and above and lengths 8mm and above), are 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. The Paltop Dental Implant System is indicated also for immediate loading, when good primary stability is achieved and with appropriate occlusal loading.

The Paltop Narrow Implant (Internal Hex and Conical Connections, for implant diameters 3.25 and lengths 10mm and above) is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the interdental spaces are limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading, when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components and update previously cleared to the Paltop Advanced Dental Solutions, Ltd product line of endosseous dental implants, abutments, and prosthetic components. Specifically, this submission seeks marketing clearance for dental implants with body diameters of 3.25 mm, 3.75 mm, 4.2 mm, 5 mm, and 6 mm various compatible abutments, two (2) cover screws, and one (1) additional abutment screw.

The subject device dental implants are self-tapping, threaded, root-form dental implants intended for the functional and aesthetic rehabilitation of the partial or fully edentulous mandible or maxilla. Once osseointegrated, the implants act as an anchor for various fixed or removable prosthetic solutions. All subject device implants are intended to be placed at the bone level (crestal position). All implants with diameters of 4.2 mm and 5.0 mm diameters allow for the option of platform switching.

Advanced, Advanced +, Dynamic, PAI, and PAI TC dental implants have an internal hex connection. Each implant line is provided with a body diameter of 3.25 mm, and interface with the Paltop Narrow Platform (NP) prosthetic components, with an interface diameter of 2.90 mm. Implants with the 3.25 mm body diameter are provided in lengths of 10, 11.5, 13, and 16 mm. Each implant line also is provided with body diameters of 3.75, 4.2, and 5 mm; these implants are provided in lengths of 8, 10, 11.5, 13, and 16 mm and interface with the Paltop Standard Platform (SP) prosthetic components, with an interface diameter of 3.65 mm.

The Advanced +, Dynamic, PAI, and PAI TC dental implant lines also are provided in a body diameter of 6 mm, in lengths of 8, 10, 11.5, 13, and 16 mm. Implants with the 6 mm body diameter interface with the Paltop Wide Platform (WP) prosthetic components, with an interface diameter of 4.4 mm. The Advanced +, Dynamic, PAI, and PAI TC dental implants have an internal threaded section (UNF 1-72) for connection to the corresponding cover screw, healing cap, abutment, or abutment screw.

The subject device conical connection implants (Dynamic Conical MC, and PCA) are provided in body diameters of 3.25, 3.75, 4.2, and 5 mm. Conical implants with the 3.25 mm body diameter are provided in lengths of 10, 11.5, 13, and 16 mm; all other body diameter sizes are provided in lengths of 8, 10, 11.5, 13, and 16 mm. All conical implants have a recessed internal section for abutment indexing, and an internal threaded section for connecting with corresponding compatible healing caps, abutments, and screws. Subject device implants with a conical geometry connect to conical connection prosthetic components. The conical connection prosthetic interface diameter is 2.9 mm.

The subject device conical connection implants (Dynamic Conical MC, and PCA) have a recessed 22° internal conical taper and a section for abutment indexing, as well as a threaded section (M1.6 x 0.35) for connection to the corresponding cover screw, healing cap, abutment, or abutment screw.

All subject device titanium abutments and screws are manufactured from titanium alloy conforming to ASTM F136.

The subject device endosseous dental abutments provide a range of cement-retained and screw-retained prosthetic solutions for dental implant restoration. Subject device abutments include seven (7) compatible implant abutment designs: Healing Caps, Straight Abutments, Angulated Abutments, Multi-Unit Abutment, Temporary Abutments, Snap-On Abutment System (SAS), and Ball Abutments for subject and non-subject device implants of the same families (Advanced, Advanced +, Dynamic, PAI, and PAI TC dental implants) and the conical healing caps are compatible with conical subject and non-subject devices (PCA, Dynamic Conical, Dynamic Conical MC). Abutments are offered in either indexed (engaging) or non-indexed (non- engaging) external connections that are compatible with the subject device implants.

Subject device abutments are compatible with the subject device implants with the internal hex connection, and the conical connection implants (subject device healing cap), as well as previously cleared compatible implants as described in Table 4 Subject Device Component Compatibilities. Subject device abutments are compatible with subject device implants according to their appropriate internal connection and platform. Subject device implants with an internal hex connection and diameter size of 3.25 mm (Advanced, Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Narrow Platform (NP) Abutments, as well as abutments cleared in K210117. Subject device implants with an internal hex connection and diameter size of 3.75 mm, 4.2 mm and 5.0 mm (Advanced, Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Standard Platform (SP) Abutments, as well as abutments cleared in K232740. The 6.0 mm diameter internal hex implants of all lengths (Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Wide Platform (WP) Abutments, as well as abutments cleared in K232740. Subject device implants with a conical connection (Dynamic Conical MC and PCA) are compatible with the subject device conical connection healing cap, as well as conical connection abutments cleared in K220200. The 5.0 mm diameter conical connection implants of all lengths (Dynamic Conical MC and PCA) are compatible with conical connection abutments cleared in K232740.

All subject device titanium abutments and screws are manufactured from titanium alloy conforming to ASTM F136.

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