Manufacturer registered with FDA
Great Lakes Dental Technologies, Ltd.
Tonawanda, NY, United States. Lists 21 dental device types with FDA across 1 registered establishment.
- Device types listed
- 21
- Brands and models
- 48
- 510(k) clearances
- 0as applicant
- Markets registered in
- 7315 registrations outside the US
- Establishments
- 1United States
Registered in 7 markets
Where regulators' registries name Great Lakes Dental Technologies, 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 | Manufacturer | Great Lakes Dental Technologies, Ltd. | 21 device types | — | Below |
| Canada | Health Canada | Registration holder | GREAT LAKES DENTAL TECHNOLOGIES | 291 | 2009–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Great Lakes Dental Technologies | 8 | 2018–2018 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Great Lakes Dental Technologies | 8 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Great Lakes Dental Technologies | 5 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Great Lakes Dental Technologies | 2 | 2005–2005 | Pure Global AI |
| Israel | AMAR | Manufacturer | Great Lakes Dental Technologies, Ltd | 1 | — | 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
Devices listed with FDA
What Great Lakes Dental Technologies, Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Biocryl ICEBiocryl ResinBiocryl XSplint Biocryl ResinVariflex | 2007 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Herbst Sleep ApplianceKlearway ApplianceMedley Gold | 2011 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | eXceedSmart Moves Complete | 2016 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | Adaptable Class III MaskGreat Lakes Face CribsNola Head gear | 2009 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Elastomeric ApplianceNAPA Appliance | 2011 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Biocryl Form-XEndureGREAT LAKES BIOCRYLInvisacrylInvisacryl UltraMemotainMOUTHGUARD MATERIALRES ScrewSmart Moves | 1992 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Nola Dryfield System and accesories | 2008 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | Duralloy WireGreat Lakes Stainless Steel wireTitanium Molybdenum | 1994 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Aligner Removal HookAligner SqueeziesCarverEZ Key | 2010 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Dentasoak | 2015 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Great Lakes Bite Registration wax | 2011 |
| Preformed ClaspEHP · Class 1 | — | Lister | Great Lakes Adams claspsGreat Lakes Arrow claspsGreat Lakes Ball clasps | 1994 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | George GaugeLucia Jig | 1992 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | LIP RETRACTOR | 2006 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | eXceed | 2016 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Bur | 2021 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | PERIO PROTECT TRAYPERIO TRAY | 2006 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | AccuGuard | 2025 |
| Dental Sonography Device for Monitoring Jaw SoundsNFQ · Class 1 | — | Maker | Great Lakes Ortho Doppler | 2010 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | eXceed | 2016 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Smart Moves Complete | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Great Lakes Dental Technologies, Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Great Lakes Orthodontics, Ltd. (5), Lang Dental Mfg. Co., Inc. (1), Univ. Dental Assoc. Department of Orthodontics (1), Village Park Orthodontics (1), Dr. Alan A. Lowe, Inc. (1), G-Ortho Lab (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Jun 2018 | K172765 | Smart Moves Complete | Great Lakes Orthodontics, Ltd. | NXC Sequential Aligner |
| 24 Mar 2016 | K150702 | Exceed Tx | Great Lakes Orthodontics, Ltd. | DYW Orthodontic Plastic Bracket |
| 4 Nov 2011 | K112397 | ORTHO-JET CRYSTAL | Lang Dental Mfg. Co., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 27 Feb 2009 | K083479 | BIOCRYL X | Great Lakes Orthodontics, Ltd. | EBI Rebasing Repairing Relining Denture Resin |
| 21 Jan 2004 | K033632 | VARIFLEX | Great Lakes Orthodontics, Ltd. | EBI Rebasing Repairing Relining Denture Resin |
| 20 Mar 1996 | K955822 | REMOVABLE HERBST APPLIANCE | Univ. Dental Assoc. Department of Orthodontics | LRK Anti-Snoring Device |
| 14 Jun 1995 | K946112 | ELASTOMERIC SLEEP APPLIANCE | Village Park Orthodontics | LQZ Jaw Repositioning Device |
| 25 May 1995 | K950763 | LOWE KLEARWAY | Dr. Alan A. Lowe, Inc. | LRK Anti-Snoring Device |
| 19 Sep 1990 | K902790 | NAPA | G-Ortho Lab | LQZ Jaw Repositioning Device |
| 29 May 1986 | K861424 | ADAPTABLE CLASS III MASK | Great Lakes Orthodontics, Ltd. | DZB Orthodontic Extraoral Headgear |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Great Lakes Dental Technologies, Ltd.FDA reg. 1316408 | TONAWANDA, NY, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1316408). 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.