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The NR Line Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. NR Line Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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Unfortunately, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text.

The document is a 510(k) premarket notification letter from the FDA regarding the "NR Line Implant System." This type of document primarily confirms that the device has been found substantially equivalent to a legally marketed predicate device. It does not contain information about acceptance criteria, detailed study designs, performance metrics of the device itself (beyond its indications for use), sample sizes for testing or training, expert qualifications, adjudication methods, or specific comparative effectiveness study results.

The letter focuses on regulatory compliance, outlining responsibilities under the Act (like registration, labeling, adverse event reporting, and good manufacturing practices). The "Indications for Use" section describes how the device is intended to be used, but this is not a performance study or a list of acceptance criteria.

To provide the information you're asking for, I would need a different type of document, such as a summary of safety and effectiveness data (which may be part of the full 510(k) submission but is not included in this letter), a clinical study report, or a detailed device specification document.

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