# Glidewell Laboratories

- Location (FDA's records): Newport Beach, CA
- FDA decisions: 3 (1997–2006): 3 510(k) clearances
- Product codes: EIH (2), LRK (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 12 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Always More Marketing, Inc.: 3 (https://510kreport.com/company/always-more-marketing)
- Dental Imagineers, LLC: 1 (https://510kreport.com/company/dental-imagineers)
- Tomed Dr. Toussaint GmbH: 1 (https://510kreport.com/company/tomed-dr-toussaint)
- Besorah Dental Solutions NZ Limited: 1 (https://510kreport.com/company/besorah-dental-solutions-nz)
- United Dental Resources Corporation: 1 (https://510kreport.com/company/united-dental-resources)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)
- American Sleep Association: 1 (https://510kreport.com/company/american-sleep-association)
- Prismatik Dentalcraft, Inc.: 1 (https://510kreport.com/company/prismatik-dentalcraft)

## Its most-cited devices
- K972424: Silentnite (1997), cited by 6
- K060104: Prismatik Clinical Zirconia (2006), cited by 5
- K050144: Prismatik Ceramic (2005), cited by 1

## Recent decisions
- K060104: Prismatik Clinical Zirconia (Mar 15, 2006)
- K050144: Prismatik Ceramic (Mar 3, 2005)
- K972424: Silentnite (Sep 18, 1997)

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