Not currently registered with FDA under this name
Great Lakes Orthodontics, Ltd.
Tonawanda, NY, United States. Named as applicant on 13 dental 510(k) clearances between 1983 and 2018. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 131983–2018
- Markets registered in
- 35 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 3 markets
Where regulators' registries name Great Lakes Orthodontics, Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Great Lakes Orthodontics, Ltd. | 13 clearances | 1983–2018 | Below |
| South Korea | MFDS | Manufacturer | Great Lakes Orthodontics, Ltd.Great Lakes Orthodontics Ltd. | 3 | 2003–2017 | Pure Global AI |
| Australia | TGA | Manufacturer | Great Lakes Orthodontics Ltd | 2 | 2004–2020 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Great Lakes Orthodontics, Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Jun 2018 | K172765 | Smart Moves Complete | NXC Sequential Aligner |
| 24 Mar 2016 | K150702 | Exceed Tx | DYW Orthodontic Plastic Bracket |
| 27 Feb 2009 | K083479 | BIOCRYL X | EBI Rebasing Repairing Relining Denture Resin |
| 15 Oct 2004 | K041718 | KELES FACEMASK | DZB Orthodontic Extraoral Headgear |
| 25 May 2004 | K040881 | METACRYL | EBI Rebasing Repairing Relining Denture Resin |
| 21 Jan 2004 | K033632 | VARIFLEX | EBI Rebasing Repairing Relining Denture Resin |
| 9 Feb 1994 | K922818 | SNORE-NO-MORE | LQZ Jaw Repositioning Device |
| 11 Jan 1993 | K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE | EBI Rebasing Repairing Relining Denture Resin |
| 19 Mar 1987 | K870908 | STEADY RESIN | EBI Rebasing Repairing Relining Denture Resin |
| 29 May 1986 | K861424 | ADAPTABLE CLASS III MASK | DZB Orthodontic Extraoral Headgear |
| 30 Mar 1984 | K840805 | ORAL SAFE | JER Mechanical Denture Cleaner |
| 4 Oct 1983 | K832425 | GREAT LAKES PASTE SOLDER | EJS Alloy Other Noble Metal |
| 26 Sep 1983 | K832359 | ORAL SAFE | JER Mechanical Denture Cleaner |
Some of these clearances are listed with FDA today by another company: Great Lakes Dental Technologies, Ltd. (5), Five Star Orthodontic Laboratory & Supply, Inc. (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.