Align Technology has gained approval for its orthodontic device, the Invisalign Palatal Expander System, from the Turkish Medicines and Medical Device Agency (TMMDA), making it commercially available nationwide.
This approval marks an advancement in orthodontic treatment options, catering to a broad range of patients.
Designed for the “rapid” expansion and maintenance of a narrow maxilla (upper jaw), the device is used to treat individuals with primary, mixed or permanent dentition.
It is a direct 3D-printed system based on patented technology, providing a customised treatment plan for each patient.
The device is developed using Align’s orthodontic software, following a digital scan of the patient's mouth with an iTero intraoral scanner.
It is part of Align's comprehensive solution for early orthodontic intervention, known as Phase I treatment.
The Invisalign Palatal Expander, along with Invisalign First aligners, claims to offer a complete treatment solution for young individuals.
These aligners are specifically designed for younger patients with various malocclusions, including those with erupting dentition and the need for dental arch expansion.
For adults, the device can be combined with surgical or other required interventions. They are removable, facilitating better oral hygiene, and can be changed daily without the need for screws.
Align Technology Europe, Middle East, and Africa (EMEA) executive vice-president and managing director Simon Beard said: "The Invisalign Palatal Expander System exemplifies Align's ongoing dedication to pioneering digital orthodontics.
“It offers enhanced efficiency for doctors and improved treatment experiences for young patients. We are excited to make this innovative 3D printed alternative to traditional palatal expanders available to even more doctors and their patients across the EMEA region."
The device is currently available in markets, including Canada, the European Union, Hong Kong, Singapore, Switzerland, the UK and the US.
Align anticipates further expansion of the product's availability, subject to regulatory approvals in additional markets.
In December 2023, the company received 510(k) clearance from the US Food and Drug Administration for the Invisalign Palatal Expander System.
