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The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

The fixtures and abutments in this system are below: 1) Fixture - Magicore (RBM) - Magicore (RBM Cutting Edge) - Magicore II (SLA) . - Magicore II (SLA Cutting Edge) 2) Abutment - Magic Angled Abutment (Screw type _Hex, Non-Hex) ● - Magic Motion - Magic Motion Housing ● - Magic Abutment (Screw type Hex, Non-Hex & Cement type Hex, Non-Hex) ● - Magic Multiunit Abutment (Cement type Hex, Non-Hex) - Magic Multiunit Cap . An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The implant-abutment connection is tight and precise fitting with internal hex, non-hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media) and Magicore II implants are treated with SLA(sand-blasted, large-grit, acid-etched).

The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The Magicore Narrow System consists of dental implants, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore Narrow implant is treated with RBM (Resorbable Blasted media) or SLA(sand-blasted, large-grit, acid-etched).

The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

This submission is to add new fixtures and abutments to the previously cleared device, Magicore System (K201981), Magicore II System (K201621), Magicore II System (K192197), and Magic UCLA Abutment System (K202418). The fixtures and abutments in this system are below: 1) Fixture - Magicore - Magicore (Cutting Edge) 2) Abutment - Magic Multiunit Abutment (Screw type - Hex, Non-Hex & Cemented type - Hex, Non-Hex) - Magic Multiunit UCLA Cylinder - Magic Multiunit Cap - Magic Abutment (Screw type Hex, Non-Hex & Cemented type Hex, Non-Hex) - Magic UCLA Cement Retained Type (Hex, Non-Hex) - Magic Cylinder (Hex, Non-Hex, Post) - Magic Multiunit Cylinder (Hex, Non-Hex, Post) - Magicore Healing Cap - Magicore Healing Cap Screw - Cylinder Screw An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The Magicore System consists of dental implants, Abutments, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media).

Premilled Titanium Block System is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician. The subject Premilled Titanium Block System has two types of blocks, Premilled Titanium Block (Hex, Non-Hex) and Magic Premilled Titanium Block (Hex, Non-hex) based on the compatible implant system.

The Magic UCLA Abutment System is intended to replace missing teeth to restore chewing function. The Magic UCLA Abutment System can be placed in support of single or multiple-unit restorations including: cement retained, screw retained, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

The Magic UCLA Abutment System is used with a dental implant to provide support to prosthetic restorations such as crowns, bridges, and overdentures in partially or fully edentulous patients. The system includes Magic UCLA Screw Retained Type (Hex, Non-Hex) and Magic UCLA Cement Retained Type (Hex, Non-Hex) abutments. The abutments are fabricated from Co-Cr-Mo Alloy with Poly Diacetate, provided non-sterile, and packaged separately. They must be sterilized before use. The abutments are not intended to be cast at angulation or placed to provide angular correction.

The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutunent support for fixed bridgework. This system is for one or two stage surgical procedures and not for immediate loading. This system is intended for delayed loading.

The IBS Implant System consists of dental implants, abutments, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with RBM (Resorbable Blasted media). This submission is to add implants and abutments to the previously cleared device, IBS Implant System (K153350).

The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

This submission is to add new implants and abutments to the previously cleared device, Magicore System (K152520). The newly added implants and abutments are below: Fixture - Magicore (4mm of Neck length Implants) . - . Magicore (Cutting Edge) Abutment - Magicore Solid Abutment - Healing Cap For Magicore Solid Abutment Cap, no other changes are being made to the previous clearance except for product name change. An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The Magicore System consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with RBM (Resorbable Blasted media).

The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

This submission is to add new abutments to the previously cleared device. Magicore II System (K192197). The newly added abutments are Magic Multiunit Abutments (Screw type – Hex. Non-Hex. Cemented type - Hex, Non-Hex) with the new angulations of 5, 10, 20°. For Magic Multiunit Cylinder, Magic Multiunit Abutment ST, and Mazic Multi Abutment Cap, no other changes are being made to the previous clearances except for model names. The Abutments are fabricated from Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The Abutments are provided non-sterile and packaged separately. The abutment should be sterilized before use.

The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

This submission is to add new magic Motion Abutment to the previously cleared device, IBS Implant System II (K162099). The Magic Motion Abutment system is composed of Magic Motion Abutment, Housing and O-ring. The Magic Motion Abutment is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). Magic Motion is an attachment-retained prosthetic product, which is used with patients with a fully edentulous maxilla. It is a one-piece structure. Various collar heights of the magic motions can be selected based on the gingival height. Magic motion does not have movement and it is a solid type.

The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The Magicore II System consists of dental implants, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore II implant is treated with SLA (sand-blasted, large-grit, acid-etched). The Fixture diameters are 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm and threaded lengths are 7, 8, 9, 10, 11, 12, 13mm in this system. The contained various abutments and screws in the system are Short Abutment, Magic Multi Abutment, Magic Multi Cylinder, Magic Multi Abutment ST, Abutment Screw, Healing Cap, Magicore Angled Abutment.