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510(k) K190583

DynaFlex by Dyna Flex — Product Code NXC

K190583 is an FDA 510(k) premarket notification submitted by Dyna Flex for the device "DynaFlex". The FDA issued a decision of Substantially Equivalent on June 27, 2019. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. Dyna Flex has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2019
Date Received
March 6, 2019
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 Dyna Flex

  • K230225 — DynaFlex Clear Brackets & Buttons (June 5, 2023)
  • K121396 — DYNAFLEX (August 14, 2012)
  • K103076 — DYNAFLEX (February 23, 2011)

Other clearances for product code NXC

  • K260527 — FACE4D Aligner (July 2, 2026)
  • 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)

FDA data resources