(44 days)
Cosmopost is intended to be used for preprosthetic stabilization of the tooth structure after endodontic treatment with largely intact crown, preprosthetic build up for damaged clinical crowns and thus resulting in loss of retention, using an indirect and direct method of attachment.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device named "Cosmopost." This type of document is a regulatory approval and does not contain information about acceptance criteria or a study that proves the device meets such criteria.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was approved based on its substantial equivalence to a predicate device, rather than through a study demonstrating specific performance against predefined acceptance criteria for the new device. Performance data, if any, would have been part of the 510(k) submission, but it's not included in this approval letter.
Therefore, I cannot provide the requested information from the provided text.
§ 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.