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510(k) K260788

Smylio Aligners by Smylio, Inc. — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2026
Date Received
March 10, 2026
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 Smylio, Inc.

  • K221537 — Nightwear Aligners (April 5, 2023)
  • K212660 — Smylio Invisible Clear Aligners (September 22, 2021)
  • K173784 — Smylic Invisible Clear Aligners (August 23, 2018)

Other clearances for product code NXC

  • 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)
  • K251616 — Clear Miracle (July 22, 2025)