# Gergens Orthodontic Lab

- Location (FDA's records): Phoenix, AZ
- FDA decisions: 2 (2013–2015): 2 510(k) clearances
- Product codes: LRK (2)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 2 (1 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
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)
- Specialty Appliance Works, Inc.: 1 (https://510kreport.com/company/specialty-appliance-works)
- Dyna Flex: 1 (https://510kreport.com/company/dyna-flex)
- Embassy Dental Laboratory: 1 (https://510kreport.com/company/embassy-dental-laboratory)

## Firms that cite its devices most
- True Function Laboratory, Inc.: 1 (https://510kreport.com/company/true-function-laboratory)

## Its most-cited devices
- K113126: Acrylic Herbst Appliance (2013), cited by 2

## Recent decisions
- K143591: Dorsal Appliance (Apr 15, 2015)
- K113126: Acrylic Herbst Appliance (Jul 17, 2013)

Source page: https://510kreport.com/company/gergens-orthodontic-lab