# Glidewell Laboratories-Sleep Devices Group

- Location (FDA's records): Irvine, CA
- FDA decisions: 1 (2012–2012): 1 510(k) clearance
- Product codes: MQC (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 2 (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
- Dental Concepts, LLC: 1 (https://510kreport.com/company/dental-concepts)
- Power Products, Inc.-Splintek: 1 (https://510kreport.com/company/power-products-splintek)
- Inventive Resources, Inc.: 1 (https://510kreport.com/company/inventive-resources)

## Firms that cite its devices most
- Ampower Dental Laboratories, LLC: 1 (https://510kreport.com/company/ampower-dental-laboratories)
- 3D Diagnostix, Inc.: 1 (https://510kreport.com/company/3d-diagnostix)

## Its most-cited devices
- K121365: Thermoformed Mouthguards (2012), cited by 2

## Recent decisions
- K121365: Thermoformed Mouthguards (Nov 20, 2012)

Source page: https://510kreport.com/company/glidewell-laboratories-sleep-devices-group