# Great Lakes Orthodontics, Ltd.

- Location (FDA's records): Tonawanda, NY
- FDA decisions: 13 (1983–2018): 13 510(k) clearances
- Product codes: EBI (5), JER (2), DZB (2), NXC (1), EJS (1), LQZ (1), DYW (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 3 (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
- Clearcorrect, LLC: 1 (https://510kreport.com/company/clearcorrect)
- Cadent, Inc.: 1 (https://510kreport.com/company/cadent)

## Firms that cite its devices most
- Sun Dental Laboratories, LLC: 1 (https://510kreport.com/company/sun-dental-laboratories)
- Ortho Lab Services, LLC: 1 (https://510kreport.com/company/ortho-lab-services)
- Johns Dental Laboratories: 1 (https://510kreport.com/company/johns-dental-laboratories)

## Its most-cited devices
- K172765: Smart Moves Complete (2018), cited by 3

## Recent decisions
- K172765: Smart Moves Complete (Jun 1, 2018)
- K150702: Exceed Tx (Mar 24, 2016)
- K083479: Biocryl X (Feb 27, 2009)
- K041718: Keles Facemask (Oct 15, 2004)
- K040881: Metacryl (May 25, 2004)
- K033632: Variflex (Jan 21, 2004)
- K922818: Snore-NO-More (Feb 9, 1994)
- K925275: Soft Denture Reline Material Elastoline (Jan 11, 1993)

Source page: https://510kreport.com/company/great-lakes-orthodontics