(287 days)
The Carbon Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.
Not Found
The provided text is a 510(k) premarket notification FDA letter for a device called "Carbon Post." This document is a regulatory approval letter and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input text. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed, but it does not detail the scientific studies or performance data that would typically be associated with such a submission.
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(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.