(80 days)
For use in the final filling of prepared root canals in adult or decidious teeth when antibacterial activity is desired in the final filling agont. Used to promote healing effects and to help provent bacterial contamination of the canal. A root canal filler with antibacterial properties indicated in cases whore antibacterial properties coupled with excellent physical characteristics for complete filling of the root canal are needed.
Antibacterial Gutta Percha
This document is an FDA 510(k) clearance letter for an "Antibacterial Gutta Percha" device, K971641. The letter indicates that the device has been found substantially equivalent to predicate devices, thus allowing it to be marketed.
However, the provided text does not contain any information regarding:
- Acceptance criteria or reported device performance.
- Study details (e.g., sample size, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details).
The letter solely focuses on the regulatory aspects of the device's clearance based on its substantial equivalence to previously marketed devices, rather than data from a clinical or performance study.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about a study, as this information is not present in the provided document.
§ 872.3850 Gutta percha.
(a)
Identification. Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.(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.