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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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