Home / News / Align Technology’s Invisalign Palatal Expander System Receives Approval from CDSCO 

Align Technology’s Invisalign Palatal Expander System Receives Approval from CDSCO 

Key Highlights: 

  • Align Technology announced that its Invisalign Palatal Expander System has been approved as a Class B medical device by the Central Drugs Standard Control Organization and is now commercially available in India for children, teens, and adults requiring palatal expansion treatment. 
  • The system is Align’s first direct 3D-printed orthodontic appliance and is designed to expand a narrow upper jaw through a series of removable, customized devices created using an iTero intraoral scanner and AI-driven treatment planning software. Each device is tailored to the patient’s anatomy to deliver gradual and controlled maxillary expansion. 
  • When combined with Invisalign First Aligners, the expander provides a complete Phase 1 early orthodontic treatment solution for young patients, traditionally managed using metal expanders or partial braces, supporting more comfortable treatment while improving oral hygiene and patient experience. 

Implications:  

Invisalign obliterates metal expander pain points, handing orthodontists a sleek digital alternative that skyrockets teen compliance and parental buy-in. 
Tier-2/3 clinics finally access premium jaw expansion tech, exploding early intervention volumes as cosmetic orthodontics goes mainstream. 
Align dominates India’s digital ortho revolution, crushing legacy players while combo systems reshape Phase 1 treatment nationwide. 

Source: Businesswire | Image: Align Technology

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