Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1316408

FEI Number

1316408

Entity Name

Great Lakes Dental Technologies, Ltd.

City/State/Country

TONAWANDA, NY, US

Establishment Address

200 COOPER AVENUE, TONAWANDA, NY 14150, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Great Lakes Dental Technologies, Ltd. (Owner Number: 1316408)

Owner / Operator Contact Address

200 COOPER AVE., --, Tonawanda, NY 14150, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2008-03-06
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2026-05-13
PNN	Orthodontic Software	Dental	Class 2	872.5470	2026-05-13
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2011-02-18
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2011-02-18
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1992-06-29
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2011-02-18
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2015-06-03
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2014-07-24
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2006-08-31
EHP	Clasp, Preformed	Dental	Class 1	872.3285	1994-07-21
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2025-11-15
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2025-11-15
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2010-04-21
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	1992-06-29
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2018-06-05
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2018-06-05
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-11-14
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2009-03-03
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	1994-03-15
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2006-05-11
NFQ	Device, Dental Sonography, For Monitoring Jaw Sounds	Dental	Class 1	872.2050	2010-02-03
EJL	Bur, Dental	Dental	Class 1	872.3240	2021-08-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Great Lakes Dental Technologies, Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1316408. Last updated year: 2026. Please use registration number 1316408 when referencing this establishment in official correspondence.