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510(k) K203737

Spark Clear Aligner System by Ormco Corporation — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2021
Date Received
December 22, 2020
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 Ormco Corporation

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

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  • 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)