(71 days)
For use during condensation of gutta percha in tooth root canals. May also be used as a pulp r of use during ochaoned. Of Samal stimulus through molten gutta percha.
Thermique Thermal Condenser
The provided text is a 510(k) premarket notification approval letter for the "Thermique Thermal Condenser." This document focuses on establishing substantial equivalence to a predicate device and does not contain information about the device's specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval document, not a clinical study report.
Therefore, I cannot provide the requested information from the given input.
§ 872.1720 Pulp tester.
(a)
Identification. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.(b)
Classification. Class II (special 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.