Home / 510(k) Clearances / K250343

510(k) K250343

LuxCreo Clear Aligner System by LuxCreo, Inc. — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2025
Date Received
February 6, 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 LuxCreo, Inc.

  • K253365 — LuxCreo Flexible Partial Denture Resin (November 25, 2025)
  • K230592 — LuxCreo Dental Night Guard Resin (January 18, 2024)
  • K212680 — LuxCreo Clear Aligner System (May 31, 2022)

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)