(101 days)
Can be used for a wide range of dental procedures including endodontic surgeries, such as drilling into the root canal, and general dentistry, such as removing carious material from the dentin.
Not Found
This is a 510(k) clearance letter for a dental handpiece (AEU-5000), which is a Class I device. Class I devices are generally exempt from premarket notification requirements if they meet certain criteria, and this letter confirms substantial equivalence without requiring a detailed performance study like those for higher-risk devices or software.
Therefore, the provided document does not contain the information requested for acceptance criteria and a study proving device performance as it would for a device requiring more rigorous testing. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is typically found in premarket submission documents for software or higher-risk devices, not in a 510(k) clearance letter for a Class I dental handpiece.
The letter simply states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise new questions of safety and effectiveness, and is as safe and effective as a legally marketed device. This equivalence is typically established based on existing standards and performance data for similar devices, rather than a new, comprehensive clinical study specifically detailed in this type of letter.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.