# Dyna Flex

- Location (FDA's records): St. Ann, MO
- FDA decisions: 4 (2011–2023): 4 510(k) clearances
- Product codes: NXC (2), NJM (1), LRK (1)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Specialty Appliance Works, Inc.: 3 (https://510kreport.com/company/specialty-appliance-works)
- Ortho Organizers, Inc.: 1 (https://510kreport.com/company/ortho-organizers)
- Allesee Orthodontic Appliances: 1 (https://510kreport.com/company/allesee-orthodontic-appliances)
- Clearcorrect, LLC: 1 (https://510kreport.com/company/clearcorrect)
- Somnomed, Inc.: 1 (https://510kreport.com/company/somnomed)
- Airway Management, Inc.: 1 (https://510kreport.com/company/airway-management)

## Firms that cite its devices most
- Oventus Manufacturing Pty, Ltd.: 1 (https://510kreport.com/company/oventus-manufacturing)
- True Function Laboratory, Inc.: 1 (https://510kreport.com/company/true-function-laboratory)
- Embassy Dental Laboratory: 1 (https://510kreport.com/company/embassy-dental-laboratory)
- Selane Products, Inc.: 1 (https://510kreport.com/company/selane-products)
- Biomodeling Solutions, Lls: 1 (https://510kreport.com/company/biomodeling-solutions-lls)
- Gergens Orthodontic Lab: 1 (https://510kreport.com/company/gergens-orthodontic-lab)

## Its most-cited devices
- K103076: Dynaflex (2011), cited by 6

## Recent decisions
- K230225: DynaFlex Clear Brackets & Buttons (Jun 5, 2023)
- K190583: DynaFlex (Jun 27, 2019)
- K121396: Dynaflex (Aug 14, 2012)
- K103076: Dynaflex (Feb 23, 2011)

Source page: https://510kreport.com/company/dyna-flex