Align Technology Announces Approval of Invisalign Palatal Expander System in India as a Class B Medical Device from the Central Drugs Standard Control Organization

Published: 2025-07-15 05:06:30 ET ALGN

Published on 07/15/2025 at 05:06

Align Technology, Inc. announced the availability of the Invisalign® Palatal Expander System in India, which has been approved as a Class B medical device by the Central Drugs Standard Control Organization (CDSCO). This innovative system offers an effective and easily removable alternative to traditional palatal expanders, eliminating the need for metal and screws. The system is designed for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla in growing patients, including children, teens, and adults.

The Invisalign Palatal Expander System is a modern, direct 3D printed device that is customized to each patient?s unique anatomy based on an iTero? intraoral digital scan. It is intended for use in conjunction with Invisalign First?

aligners, providing a comprehensive early intervention treatment solution for orthodontic care.