Align Technology, a US-based orthodontics company, has announced that its Invisalign Palatal Expander System has secured approval in Turkey.
The Turkish Medicines and Medical Device Agency (TMMDA) has approved the product, which is now available for commercial use.
This approval covers many patients, including growing children, teens, and adults with surgery or other techniques.
Invisalign Palatal Expander System is a 3D printed device which uses proprietary, patented technology. It is intended for the orthodontic treatment of malocclusion and offers an alternative to traditional palatal expanders.
Designed for rapid expansion and holding of skeletal and/or dental narrow maxillas (upper jaws), it is intended for patients with primary, mixed, or permanent dentition.
In November last year, the medical device firm secured the CE Mark approval in Europe for the Invisalign Palatal Expander System.
The system is already available in the US, Canada, Australia, New Zealand, Hong Kong, Singapore, the UK, UAE, and Switzerland.
It is expected to expand to additional markets pending regulatory approvals.
Align Technology executive vice president and chief clinical officer Mitra Derakhshan said: “Together with Invisalign First aligners, Invisalign Palatal Expanders enables Align Technology to provide doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children.
“The addition of mandibular advancement features to Invisalign aligners also provides doctors with more options for treating skeletal and dental jaw imbalances and bite correction for their growing patients during their teenage years.”
The Invisalign Palatal Expander System includes a series of removable devices, designed to gradually expand a patient’s narrow maxilla in small, precise increments to a predetermined position.
Each 3D printed device is custom-made to fit the patient’s anatomy, based on an iTero intraoral digital scan.
The treatment plan and device design are created using Align Technology’s proprietary orthodontic software.
Invisalign First aligners and Invisalign Palatal Expanders offer doctors a complete Phase 1 early intervention solution for young patients.
Phase 1 treatment typically occurs between ages six and 10, before all permanent teeth have erupted, and traditionally involves arch expanders or partial metal braces.
Invisalign First aligners are tailored to address various malocclusions in younger patients, including shorter clinical crowns, managing erupting teeth, and ensuring predictable dental arch expansion.
Align Technology designs and manufactures the Invisalign System, an advanced clear aligner system, with iTero intraoral scanners and exocad CAD/CAM software.
These technologies are designed to enhance digital orthodontic and restorative workflows.
