FDA Registration
Active
🇺🇸 United States
Great Lakes Dental Technologies, Ltd.
Reg #: 1316408
·
FEI: 1316408
·
Expires 2026
Products
24
Proprietary Names
47
Establishment Types
4
Classifications
24
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Registration Details
- Registration Name
- Great Lakes Dental Technologies, Ltd.
- Registration Number
- 1316408
- FEI Number
- 1316408
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 200 COOPER AVENUE
- City
- TONAWANDA
- State
- NY
- ZIP
- 14150
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221845
Owner / Operator
- Firm Name
- Great Lakes Dental Technologies, Ltd.
- Operator Number
- 1316408
- Address
- 200 COOPER AVE., --
- City
- Tonawanda
- State
- NY
- Postal Code
- 14150
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2008-03-06 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2026-05-13 |
| Orthodontic Software | PNN | Class 2 | Dental | No | 2026-05-13 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2011-02-18 |
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2011-02-18 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 1992-06-29 |
| Headgear, Extraoral, Orthodontic | DZB | Class 2 | Dental | No | 2011-02-18 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2015-06-03 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2014-07-24 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2006-08-31 |
| Clasp, Preformed | EHP | Class 1 | Dental | No | 1994-07-21 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2025-11-15 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2025-11-15 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2010-04-21 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 1992-06-29 |
| Bracket, Plastic, Orthodontic | DYW | Class 2 | Dental | No | 2018-06-05 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 1994-03-15 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2006-05-11 |
| Device, Dental Sonography, For Monitoring Jaw Sounds | NFQ | Class 1 | Dental | No | 2010-02-03 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2021-08-11 |
| Device, Jaw Repositioning | LQZ | Class 2 | Dental | No | 2011-02-18 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2016-03-29 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2016-03-29 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2016-05-16 |
Proprietary Names
Nola Dryfield System and accesories
MARPE
Great Lakes Bite Registration wax
Klearway Appliance
George Gauge
Lucia Jig
Adaptable Class III Mask
Dentasoak
Biocryl ICE
LIP RETRACTOR
Great Lakes Ball clasps
Great Lakes Adams clasps
Great Lakes Arrow clasps
AccuGuard
EZ Key
Aligner Removal Hook
Aligner Squeezies
Carver
Invisacryl
Invisacryl Ultra
RES Screw
GREAT LAKES BIOCRYL
MOUTHGUARD MATERIAL
Smart Moves
Endure
Biocryl Form-X
Memotain
Smart Moves Complete
Variflex
Splint Biocryl Resin
Biocryl Resin
Great Lakes Stainless Steel wire
Duralloy Wire
Titanium Molybdenum
PERIO TRAY
PERIO PROTECT TRAY
Great Lakes Ortho Doppler
Bur
Biocryl X
Herbst Sleep Appliance
NAPA Appliance
Medley Gold
Elastomeric Appliance
eXceed
RHEA Occlusal Appliance
Great Lakes Face Cribs
Nola Head gear
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)