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510(k) K190583

DynaFlex by Dyna Flex — Product Code NXC

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

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  • K103076 — DYNAFLEX (February 23, 2011)

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  • K251415 — Additively Manufactured Aligner Resin (August 27, 2025)
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