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Nobel Biocare Endosseous Implants are indicated for maxillofacial use. They are intended to be used as the foundation for anchoring prosthesis or epithesis in the craniofacial region.

This submission extends the indication for the Nobel Biocare Endosseous Implants to use in maxillofacial reconstructive surgery. There is no change to existing product marketed for dental applications.

The provided text is a 510(k) summary and related correspondence for the Nobel Biocare Endosseous Implants for Maxillofacial Indication. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is focused on extending an existing indication.

Therefore, I cannot provide the requested information from the given text.

The document indicates that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require new performance studies to demonstrate safety and effectiveness for the extended indication. Instead, the focus is on the device description and its intended use.

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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.

This document is a 510(k) summary for Nobel Biocare Endosseous Implants. It does not contain any information regarding acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically focuses on comparing the new device's design, materials, and intended use to an existing predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot extract the requested information (points 1-9) from this document.

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