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The Nobel Biocare Replace TiUnite Endosseous Implant is intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.

If the single stage procedure is used, these implants may be loaded immediately following insertion -- provided -- at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.

The Replace TiUnite endosseous implant is a threaded root-form dental implant. It comes in widths of 3.5mm, 4.3mm, 5.0mm, and 6.0mm. Each width comes in lengths of 10mm, 13mm, and 16mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean

This document is a 510(k) summary for the Replace TiUnite Endosseous Implant, an endosseous dental implant. It primarily focuses on the regulatory submission and does NOT contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The provided text details the device description, indications for use, and a letter from the FDA confirming substantial equivalence to a predicate device, which is part of the regulatory approval process but does not include clinical study data or performance metrics.

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