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Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

The Zygoma Implant is a titanium endosseous implant longer than traditional endosseous implants. The Zygoma Implant is intended to extend through the maxillary sinus into the Zygomaticus bone. The Zygoma Implant is particularly useful when there is insufficient bone for a traditional implant.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, results of a study, sample sizes, data provenance, expert qualifications, ground truth establishment, or any other details related to a study proving the device meets acceptance criteria.

The document is a 510(k) summary and FDA clearance letter for a dental implant. It describes the device, its indications for use, and confirms its substantial equivalence to legally marketed predicate devices. It does not include information on specific performance studies or acceptance criteria.

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