DynaFlex

Aligner, Sequential

DynaFlex

The following data is part of a premarket notification filed by Dynaflex with the FDA for Dynaflex.

Pre-market Notification Details

• Device ID: K190583
• 510k Number: K190583
• Device Name: DynaFlex
• Classification: Aligner, Sequential
• Applicant: DynaFlex 10403 International Plaza Dr. St. Ann, MO 63074
• Contact: Matthew Malabey
• Correspondent: Matthew Malabey; DynaFlex 10403 International Plaza Dr. St. Ann, MO 63074
• Product Code: NXC
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-06
• Decision Date: 2019-06-27