Rotary/reciprocating endodontic file/rasp, single-use - ARTG 469926
Access comprehensive regulatory information for Rotary/reciprocating endodontic file/rasp, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 469926 and sponsored by Acteon Australia/New Zealand, manufactured by FKG Dentaire Sarl in Switzerland. The device registration started on November 22, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
This is a device that is intended for endodontic treatment. This is a dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol) and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer.