(68 days)
The X-TIP Intraosseous Perforator is intended as a disposable delivery apparatus and method for intraosseously delivering dental anesthesia in a simple, safe and effective manner directly into cancellous bone.
Not Found
This document is an FDA 510(k) clearance letter for the X-TIP Intraosseous Perforator. It primarily addresses the regulatory approval process and states the device's intended use. It does not contain any information regarding specific acceptance criteria for device performance or a study proving that the device meets such criteria.
Therefore, I cannot provide the requested information. The letter only confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not detail performance data or studies.
§ 872.4730 Dental injecting needle.
(a)
Identification. A dental injecting needle is a slender, hollow metal device with a sharp point intended to be attached to a syringe to inject local anesthetics and other drugs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.