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GM Helix Implant:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The GM Helix Implant System with 3.75 and 4.0 diameter and 18 mm length are indicated for surgical installation in the pterygoid region (upper jaw), for multiple unit restorations, when combined with 45° angulation abutment, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Implants in the pterygoid indication should be used in splinted applications that utilize at least two implants.

GM Helix LG Implant:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. The GM Helix LG Implant System is indicated for surgical installation in the pterygoid region (upper jaw), for multiple unit restorations, when combined with 45° angulation abutment, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

GM Mini Conical Abutment 45°:
The Mini Conical Abutments 45° and 60° are indicated for use with Zygomatic Implants, in cases of severe jaw resorption, in order to restore patient aesthetics and chewing function. The Mini Conical Abutments 45° are also indicated for use with Pterygoid implants in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The Mini Conical Abutments may be used with single stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

GM Mini Conical Abutment 45° Slim:
The Mini Conical Abutments 45° and 52° are indicated for surgical procedures in Zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. The Mini Conical Abutments 45° are also indicated for use with Pterygoid implants in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The Mini Conical Abutments may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.

This premarket notification seeks to expand the indications for use of the subject implants and abutments, in order to include anchorage in the pterygoid region. These devices were previously cleared under 510(k) K163194, K190958, K190718 and K232099 for the functional and esthetic oral rehabilitation of the upper or lower jaw in edentulous or partially edentulous patients. The proposed implants and abutments remain with the same design and features already cleared in the original submission.

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