DYNAFLEX

Aligner, Sequential

DYNA FLEX

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

Pre-market Notification Details

• Device ID: K121396
• 510k Number: K121396
• Device Name: DYNAFLEX
• Classification: Aligner, Sequential
• Applicant: DYNA FLEX 10403 International Plaza Dr. Northwest Plaza, MO 63074
• Contact: Matthew Malabey
• Correspondent: Matthew Malabey; DYNA FLEX 10403 International Plaza Dr. Northwest Plaza, 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: 2012-05-09
• Decision Date: 2012-08-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D8410091L1D	K121396	000
D84100911Z	K121396	000