Device Dossier
Rotary/reciprocating endodontic file/rasp, single-use
Device Dossier for Rotary/reciprocating endodontic file/rasp, single-use (Rotary/reciprocating endodontic file/rasp, single-use, Class IIa, sponsor…
- GMDN category: Rotary/reciprocating endodontic file/rasp, single-use
Intended purpose
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.