www.fdanews.com/articles/188919-fda-grants-premarket-notification-clearance-for-orthocaps-aligners
FDA Grants Premarket Notification Clearance for Orthocaps’ Aligners
October 24, 2018
Orthocaps’ aligners, invisible braces for teenagers and adults, have received the FDA’s 510(k) premarket notification clearance.
The aligners have a clear appearance and come with a unique treatment program to handle complex cases.
The invisible braces have a dual layer polymer, including a soft inner tray that improves grip and a firm outer tray for improved force application.