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510(k) K222894

Invisalign System, Pre-Formed Attachment System by Align Technology, Inc. — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2022
Date Received
September 23, 2022
Clearance Type
Traditional
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.

  • K252931 — Invisalign® Palatal Expander System (October 23, 2025)
  • 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)
  • 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)
  • K252931 — Invisalign® Palatal Expander System (October 23, 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)