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510(k) K240038

Clear Moves Aligners by Space Maintainers Laboratories (Sml) — Product Code NXC

K240038 is an FDA 510(k) premarket notification submitted by Space Maintainers Laboratories (Sml) for the device "Clear Moves Aligners". The FDA issued a decision of Substantially Equivalent on April 4, 2024. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2024
Date Received
January 5, 2024
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 for product code NXC

  • K260788 — Smylio Aligners (May 8, 2026)
  • K260722 — SureSmile Aligner (ASSY500020) (April 15, 2026)
  • 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)

FDA data resources