Cleared Traditional

DynaFlex

K190583 · Dyna Flex · Dental
Jun 2019
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K190583 is an FDA 510(k) clearance for the DynaFlex, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Dyna Flex (St. Ann, US). The FDA issued a Cleared decision on June 27, 2019, 113 days after receiving the submission on March 6, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K190583 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2019
Decision Date June 27, 2019
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NXC — Aligner, Sequential
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.