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510(k) K203339

NEOLab Clear Aligners by New England Ortho Lab, Inc. — Product Code NXC

K203339 is an FDA 510(k) premarket notification submitted by New England Ortho Lab, Inc. for the device "NEOLab Clear Aligners". The FDA issued a decision of Substantially Equivalent on Jan 6, 2021. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. New England Ortho Lab, Inc. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 6, 2021
Date Received
Nov 12, 2020
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
510(k)

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

Other clearances by New England Ortho Lab, Inc.

  • K192338 — NEOLab Clear Aligners (Mar 12, 2020)

Other clearances for product code NXC

  • K260527 — FACE4D Aligner (Jul 2, 2026)
  • K260788 — Smylio Aligners (May 8, 2026)
  • K260722 — SureSmile Aligner (ASSY500020) (Apr 15, 2026)
  • K253282 — ZSmile System (Feb 3, 2026)
  • K251454 — Clear Aligner (SCF-3348) (Jan 7, 2026)
  • K250739 — Primeprint Direct Aligner (Nov 7, 2025)
  • K252931 — Invisalign® Palatal Expander System (Oct 23, 2025)
  • K252870 — Invisalign Specifix Attachment System (Oct 9, 2025)
  • K251758 — Serafin® (Sep 11, 2025)
  • K252380 — Invisalign System (Aug 29, 2025)

FDA data resources