Device Dossier

Dental power tool handpiece motorless component

Device Dossier for Dental power tool handpiece motorless component (Dental power tool handpiece motorless component, Class IIa, sponsor Henry Schein…

Intended purpose

This range of medical device / dental handpieces (straight and or contra angle) is designed to be used with the corresponding heads in the following applications: Cavity preparation and endodontics (S81 / S321 / L52 / L62 / L67 / L68B) In combination with a polishing tool to support the periodontal treatment by polishing with a rotating tool (S19 / S31 / E31 / L31) The removal of caries, drilling, removal of fillings, surface processing as well as the polishing and smoothing of dental and restoration surfaces (S10 / E10). Drilling, caries excavation, endodontics, processing of tooth and restoration surfaces (S20 / E15 / E20) Endodontics as well as support for periodontal treatment by means of polishing (S53 / L53) Removal of carious material, cavity and crown preparations, removal of fillings, processing of tooth and restoration surfaces (E25 / M25 / M05) Depending on the files employed, the medical device can be used for the finishing of box preparations, for bevelling in composite fillings and inlays / onlays, for edge finishing in crowns as well as for the removal of rough, proximal filling surfaces and edges of crowns (E61). Drilling, processing of tooth and restoration surfaces (L80) Endodontics (L3 / L3Y) The INTRA EVA head L61 G/R can be used in combination with Proxoshape, Bevelshape, Cavishape, Rootshape files, Ortho-Strips as well as the Margin-Shaper made by Intensiv in the appropriate indications (L61 R / L61 G) Microsurgery (L22)

TGA Public Summary