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Nobel Biocare's Modified Surface Implant is intended to be placed in the upper or lower iaw 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.

Nobel Biocare's Modified Surface Implant is a threaded, hex-lock root-form dental implant. It is 3.75-mm in diameter and is available in lengths ranging from 7-mm to 20mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean

The provided text is a 510(k) summary for Nobel Biocare's Modified Surface Implant, a dental implant. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria through a clinical study. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document.

510(k) summaries primarily focus on:

• Device Description: What the device is.
• Intended Use: What the device is for.
• Comparison to Predicate Devices: Showing how the new device is similar to legally marketed devices.
• Technological Characteristics: Details about the materials, design, and function.

The document states "The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean

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