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510(k) K250487

SparkTM Clear Aligner System by Ormco Corporation — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2025
Date Received
February 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Ormco Corporation

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  • K240501 — Spark™ Clear Aligner System (October 11, 2024)
  • K203737 — Spark Clear Aligner System (March 22, 2021)
  • K172845 — Symetri Clear (January 31, 2018)
  • K171844 — Inspire ICE aka Inspire ICE Clear Brackets (July 18, 2017)

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)