(35 days)
PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.
PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin. PULPDENT Endo-Prep II will be offered in two viscosities, thin and thick, so that the dentist can apply the product either directly to the canal ovening or to the file.
This document does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a "SUMMARY OF SAFETY AND EFFECTIVENESS DATA" for a dental product called PULPDENT Endo-Prep II, which is a chelating agent used in root canal procedures.
The document focuses on comparing PULPDENT Endo-Prep II to predicate devices, stating its substantial equivalence in composition and intended use. It references a publication by the American Dental Association regarding the general effectiveness of EDTA as a chelating agent.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study based on the provided text, as this information is not present.
§ 872.3840 Endodontic silver point.
(a)
Identification. An endodontic silver point is a device made of silver intended for use during endodontic therapy to fill permanently the root canal of a tooth.(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.