(217 days)
The boneTRAP is designed for use in various oral surgical procedures (implant surgery, periodontal surgery, etc.) where the oral surgeon desires to collect a patient's own bone particles and other tissue fragments for later use in bone or tissue transplantation.
boneTRAP is a sterile, disposable plastic trap for collecting bone particles.
The provided text is a 510(k) premarket notification letter from the FDA regarding the "BoneTRAP" device. This type of document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot extract the requested information from the given text. The letter only states that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include technical specifications, study methodologies, or performance metrics.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.