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NOBELSPEEDY™ Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NOBELSPEEDY™ Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare NOBELSPEEDY™ Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

NOBELSPEEDY™ Implants are indicated for use in soft bone or whenever immediate or early loading is applied. The NOBELSPEEDY™ Implants incorporate a groove on the implant thread and are preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants. In addition, the NOBELSPEEDY™ Implants are preferred in these soft bone indications because bone formation on the TiUnite® surface is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates.

NOBELSPEEDY™ Implants may be tilted up to 45°. When used with angulations between 30° and 45° a minimum of four implants must be used and splinted.

Nobel Biocare's NOBELSPEEDY" Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

NOBELSPEEDY" Implants incorporate a groove on the threads of the implant and have a tapered apex. NODELOT LED I " implants interperate a yallable with a straight contour. NOBELSPEEDY" Implants have a surface treatment consisting of a titanium oxide layer, (TiUnite®), which extends from the implant threads onto the implant collar.

Nobel Biocare's NOBELSPEEDY" 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 Surgical procedure of a two clayour post post initial stability of the implant can be obtained. NOBELSPEEDY™ Implants can be placed in soft bone and under-prepared sites.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The document is a 510(k) summary for a dental implant device, primarily describing its features, indications for use, and regulatory classification. It does not include study details of the type you are asking for.

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