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Nobel Biocare's NOBELREPLACE® Adapter is a bushing that enables seating of a smaller diameter abutment to a larger diameter endosseous implant in an implant-supported dental restoration of a partially or fully edentulous jaw in order to restore patient esthetics and chewing function.

Nobel Biocare's NOBELREPLACE® Adapter is a hollow titanium alloy device intended for use as an accessory component designed to adapt a smaller platform abutment to a larger platform endosseous implant to a within the implant/abutment system. The NOBELREPLACE® Adapter provides a gradual transition from abutment to implant, and can only be used as part of the implant/abutment system, not on its own. It is designed to remain a component of the implant/abutment system for as long as the implant remains in the patient's mouth.

Nobel Biocare's Procera® Abutment Brånemark is indicated for the treatment of partially edentulous patients requiring a prosthetic device. In addition to the Brånemark implant, the abutment's hexagon connector fits the external hexagon of the following endosseous implants: - 3i® 3.75 - Lifecore® Biomedical Restore 3.75 - Zimmer® Dental Taperlock 4.0 - Sterngold Implamed® 3.75

The Procera® Abutment Brânemark is an artificial tooth abutment designed to fit and function on root-form endosseous implants having an external hexagon abutment interface. Nobel Biocare's Procera® Abutment Brånemark is intended for use in the treatment of partially edentulous patients in arder to restore chewing function. The Procera® Abutment Brånemark is a prosthetic device panonto in brace's Brånemark external hexagon endosseous implant as well as the endosseous implants specifically indicated. The device has been developed for long-term, permanent use. Nobel Biocare's Procera® Abutment Brånemark can be made from titanium, alumina, or zirconia.

Nobel Biocare Endosseous Implants are indicated for use as root form endosseous implants in partially or fully edentulous patients for the purpose of restoring chewing function. Implants may be tilted up to 45°. When used with angulations between 30° and 45°, the following applies: - the tilted implants must be splinted - a minium of four implants must be used when supporting a fixed prosthesis in a fully edentulous arch

Nobel Biocare Endosseous Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function to partially or fully edentulous patients. Nobel Biocare Endosseous Implants are machined from titanium and available straight or tapered. The implants are either a) coated with hydroxyapatite powder, i.e. HA coated implants; b) have a surface treatment of the implant that consists of a titanium oxide layer, i.e. TiUnite implants; or c) do not have any coating or surface treatment, i.e. Branemark implants. Nobel Biocare Endosseous Implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion. Nobel Biocare Endosseous Implants can be placed anywhere in the upper or lower jaw where good initial stability of the implant can be obtained.

The NobelDirect™ OD Implant is a root form endosseous implant intended to provide immediate retention for removable tissue supported lower dentures in fully edentulous patients. The NobelDirect™ OD Implant is a root form endosseous implant intended to provide immediate retention for a removable tissue supported overdenture. The NobelDirect™ OD Implant is intended for placement in the interforaminal area of the anterior mandible for the fully edentulous lower arch.

Nobel Biocare's NobelDirect™ OD Implant is a threaded one-piece root form endossions with an integrated ball attachment designed for one-stage surgical procedures and overdenture restorations. The integratou ball attablimont as intended to provide immediate retention for removable tissue supported lower overdentures in fully edentulous jaws. Nobel Biocare's NobelDirect™ OD Implant can be placed in an edentulous arch or piaced simultaneously Nobel Diocare 3 Nobel Biocare's Nobel Biocare's NobelDirect™ OD Implant in immediate function applications, it is essential to obtain primary implant stability. Nobel Biocare's Gold Cap for Ball Attachment is to be utilized with the NobelDirect™ OD Implant. Nobel Biocare's NobelDirect™ OD Implant is machined from titanium and is available with a straight or tapered contour. The NobelDirect™ OD Implant has a surface treatment that consists of a titanium oxide layer (TiUnite) that extends over the implant threads and onto the implant collar.

NobelRondo Dental Ceramic Alumina is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from alumina.

NobelRondo Dental Ceramic – Alumina is dental porcelain intended for use in the construction of aluminum oxide ceramic prosthetics. NobelRondo consists of sixteen (16) porcelain shades corresponding to Vita shades A0-C3 and various shade modifiers. The shade modifiers are intended to give the user flexibility in creating a translucent or opalescent natural looking prosthetic. NobelRondo also includes mixing liquids and shade guides. The various porcelains and modifiers are used in a build-up process. After applying each layer, the restoration is fired following directions in the Instructions for Use. All of the component porcelains and modifiers can be used in combination without restriction. The dental technician will use the components as needed to create the desired prosthetic. However, typical use includes using a base liner followed by a build-up material and finally glazes and stains. Throughout this process, modifiers for translucent and opalescent effects can be added. The NobelRondo Dental Ceramic – Alumina is sold in kit form. The various porcelains and modifiers are packaged in polyethylene bottles with screw caps. Replacement bottles for each porcelain or modifier are available individually.

Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous patients requiring prosthetic devices that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.

The Procera® Abutment Octagon is an artificial tooth abutment designed to fit and function on the Straumann Dental Implant System regular neck 4.8mm endosseous implant. Nobel Biocare's Procera® Abutment Octagon is intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Procera® Abutment Octagon is a prosthetic device that fits only the Straumann regular neck 4.8mm endosseous implant. The device has been developed for long-term, permanent use. Nobel Biocare's Procera® Abutment Octagon can be made from either titanium or zirconia.

The Nobel Biocare Permanent Centric Post is a support component indicated for use as both an alignment post to center an abutment, and as a seal to prohibit fluids from seeping into the implant interior. The Nobel Biocare Permanent Centric Post is a component within the endosseous implant system, and is intented for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.

Nobel Biocare's Permanent Centric Post is a hollow, accessory component designed to enhance the performance of the implant/abutment system by ensuring proper alignment between an abutment and an endosseous implant, while additionally acting as a seal that prevents fluids from seeping into the implant interior. The Nobel Biocare Permanent Centric Post does not contact any mucous membranes in the oral cavity because it rests inside the implant/abutment interface. The Centric Post can only be used as part of the implant system, not on its own. It is designed to remain inside the implant/abutment interface for as long as the implant remains in the patient's mouth.

The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center an abutment and as a seal to prohibit fluids from seeping into the implant interior. The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients. The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center a temporary abutment and act as a seal to prohibit fluids from seeping into the implant interior during temporization. The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.

Nobel Biocare's Centric Post is a hollow, accessory component designed to enhance the performance of the implant/abutment system by ensuring proper alignment between an abutment and an endosseous implant, while additionally acting as a seal that prevents fluids from seeping into the implant interior. The Nobel Biocare Centric Post does not contact any mucous membranes in the oral cavity because it rests inside the implant/abutment interface. The Centric Post can only be used as part of the implant system, not on its own. It is designed to remain inside the implant/abutment interface for as long as the implant remains in the patient's mouth. These attributes of the Nobel Biocare Centric Post enhance the performance of the implant/abutment system, such as the Nobel Perfect Implant System, and make the component desirable for use in fabricating both final restorations and temporary restorations.

The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Nobel Biocare's Nobel Direct is a name change of the legally marketed device "Replace" One Piece Implant" (K023952). Nobel Biocare's Nobel Direct utilizes the same material and fundamental design as the unmodified, predicate device, "Replace" One Piece Implant" (K023952). Nobel Biocare's Nobel Direct incorporates a design modification by adding an endosseous implant with a diameter of 3.0mm to the existing diameter sizes already in the Nobel Direct product line. The Nobel Direct 3.0mm implant is restricted for use only in the maxillary lateral position or the mandibular central and lateral incisor position. The Nobel Direct 3.0mm implant/abutment is only available in lengths of 13mm and 15mm. The implant represent the portion of the unit placed in the bone (i.e. threaded portion).

The indications for use for the Nobel Perfect Implant System are the unmodified device, Replace Scalloped Margin Implant System. It is a system with a scalloped coronal implant designed for single stage or two stage surgical procedures. The Nobel Perfect Implant System is intended for use to restore chewing function in edentulous and/or partially edentulous patients.

The Nobel Perfect Implant System is a name change of the legally marketed device Replace Scalloped Margin Implant System. The Nobel Perfect Implant System utilizes the same components (i.e. implant, abutment, etc.) as the predicate device, Replace Scalloped Margin Implant System (K021584), yet contains three design modifications. First, the screw-retained healing cap is now designed as a shorter, cover plug. The design modification was developed in order to attain a better seal and reduce the overall height of the implant by lowering its profile. Second, a silicone o-ring has been added to the implant system. The o-ring is intended to be placed between the implant and the healing abutment in order to prevent fluids and tissue from seeping between the two parts during the healing process. Third, changes in materials have been specified. The material used to manufacture the former screw-relained healing cap was acetal (Delrin). The cover plug and the o-ring will be made from a medical grade translucent silicone. The material used for the manufacture of the healing abutment has changed from acetal (Delrin) to polysulfone so that it may be radiation sterilized.