Quality
Gentlefile was founded in order to supply high-quality instruments and aids to dentists, allowing them to optimize their dental procedures. The management of Gentlefile places high importance on the quality of the products provided by Gentlefile.
In order for us to ensure the quality of the products, Gentlefile has implemented a strict quality system that dictates all of the various stages of the design, production and distribution of our devices.
As a regulated manufacturing facility, Gentlefile is fully in compliance with ISO 13485:2016.
Our facility is inspected regularly to ensure we are in compliance with the requirements set forth by ISO 13485