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The B&R device is a contra-angle intended for dental implant surgery i.e. drilling procedures prior to the placement of implant prosthetics in the jaw bone.

The B&R device is a contra-angle.

The provided document is a 510(k) clearance letter from the FDA for a dental handpiece, the "B&R Device." It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it's a clearance for a medical device based on substantial equivalence to a predicate device rather than a performance study.

Therefore, I cannot provide the requested information based on the given document.

This type of FDA letter confirms that a new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if there are differences, they do not raise new questions of safety or effectiveness. The detailed performance data, acceptance criteria, and study results you're asking for would typically be found in the 510(k) submission itself or in published clinical studies, not in the clearance letter.

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