PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT

• K Number: K012427
• Device Name: PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
• Manufacturer: SPECIALITES SEPTODONT
• Date Cleared: 2001-10-09 ( 70 days)
• Product Code: EAT
• Regulation Number: 872.1720
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K830105

Intended Use

Pharmaéthyl® Local pulp and vitality testing agent is indicated as topical pulp and tooth vitality testing agent.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the device "Pharmaethyl Local Pulp and Vitality Testing Agent" and its Indications for Use statement. However, it does not contain any information about acceptance criteria, device performance, study details (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.

This document is a regulatory approval, stating that the device is substantially equivalent to a predicate device, and does not include the technical study report that would contain the requested information.

Therefore, I cannot provide the requested table and study details based on the input text.

Regulation Number and Section

§ 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.