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510(k) K252931

Invisalign® Palatal Expander System by Align Technology, Inc. — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2025
Date Received
September 15, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aligner, Sequential
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

Other clearances by Align Technology, Inc.

  • K252870 — Invisalign Specifix Attachment System (October 9, 2025)
  • K252380 — Invisalign System (August 29, 2025)
  • K240573 — iTero Lumina™ Pro (August 16, 2024)
  • K241412 — Invisalign System (June 18, 2024)
  • K232887 — Invisalign Palatal Expander System (December 15, 2023)
  • K232233 — Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (September 26, 2023)
  • K222894 — Invisalign System, Pre-Formed Attachment System (December 22, 2022)
  • K220287 — Invisalign System (April 7, 2022)
  • K193659 — iTero Element 5D (March 20, 2020)
  • K181739 — Invisalign System with Mandibular Advancement Feature (October 26, 2018)

Other clearances for product code NXC

  • K253282 — ZSmile System (February 3, 2026)
  • K251454 — Clear Aligner (SCF-3348) (January 7, 2026)
  • K250739 — Primeprint Direct Aligner (November 7, 2025)
  • K252870 — Invisalign Specifix Attachment System (October 9, 2025)
  • K251758 — Serafin® (September 11, 2025)
  • K252380 — Invisalign System (August 29, 2025)
  • K251415 — Additively Manufactured Aligner Resin (August 27, 2025)
  • K251616 — Clear Miracle (July 22, 2025)
  • K242637 — MEM Clear Aligner System (May 21, 2025)
  • K250343 — LuxCreo Clear Aligner System (April 8, 2025)