Data / Medical devices / United States / Great Lakes Dental Technologies, Ltd.

Great Lakes Dental Technologies, Ltd.: FDA-registered device maker in Tonawanda, NY, United States, 11 510(k) clearances

Name: Great Lakes Dental Technologies, Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Great Lakes Dental Technologies, Ltd. is registered with the FDA (registration 1316408) in Tonawanda, NY, United States. It lists 23 device types. The FDA files 11 510(k) clearances under its listings, the newest dated January 18, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1316408
Address: 200 Cooper Avenue, Tonawanda, NY, United States, 14150
Owner or operator: Great Lakes Dental Technologies, Ltd. (1316408)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: June 29, 1992
Registered through: 2026
Brand names listed: AccuGuard, Adaptable Class III Mask, Aligner Removal Hook, Aligner Squeezies, Biocryl Form-X, Biocryl ICE, Biocryl Resin, Biocryl X and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Aligner, Sequential	NXC	2	Manufacturer	accessdata.fda.gov
Bracket, Ceramic, Orthodontic	NJM	2	Manufacturer	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Manufacturer	accessdata.fda.gov
Bracket, Plastic, Orthodontic	DYW	2	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Repackager or relabeler	accessdata.fda.gov
Clasp, Preformed	EHP	1	Repackager or relabeler	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Specification developer	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Device, Dental Sonography, For Monitoring Jaw Sounds	NFQ	1	Specification developer	accessdata.fda.gov
Device, Jaw Repositioning	LQZ	2	Manufacturer	accessdata.fda.gov
Headgear, Extraoral, Orthodontic	DZB	2	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Repackager or relabeler	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Manufacturer	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Protector, Dental	BRW	1	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Specification developer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tray, Fluoride, Disposable	KMT	1	Contract manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Specification developer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Specification developer	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 18, 2024	K230592	LuxCreo Dental Night Guard Resin	MQC	Substantially Equivalent	LuxCreo, Inc.	accessdata.fda.gov
June 1, 2018	K172765	Smart Moves Complete	NXC	Substantially Equivalent	Great Lakes Orthodontics, Ltd.	accessdata.fda.gov
March 24, 2016	K150702	Exceed Tx	DYW	Substantially Equivalent	Great Lakes Orthodontics, Ltd.	accessdata.fda.gov
November 4, 2011	K112397	ORTHO-JET CRYSTAL	EBI	Substantially Equivalent	Lang Dental Mfg. Co., Inc.	accessdata.fda.gov
February 27, 2009	K083479	BIOCRYL X	EBI	Substantially Equivalent	Great Lakes Orthodontics, Ltd.	accessdata.fda.gov
January 21, 2004	K033632	VARIFLEX	EBI	Substantially Equivalent	Great Lakes Orthodontics, Ltd.	accessdata.fda.gov
March 20, 1996	K955822	REMOVABLE HERBST APPLIANCE	LRK	Substantially Equivalent	Univ. Dental Assoc. Department of Orthodontics	accessdata.fda.gov
June 14, 1995	K946112	ELASTOMERIC SLEEP APPLIANCE	LQZ	Substantially Equivalent	Village Park Orthodontics	accessdata.fda.gov
May 25, 1995	K950763	LOWE KLEARWAY	LRK	Substantially Equivalent	Dr. Alan A. Lowe, Inc.	accessdata.fda.gov
September 19, 1990	K902790	NAPA	LQZ	Substantially Equivalent	G-Ortho Lab	accessdata.fda.gov
May 29, 1986	K861424	ADAPTABLE CLASS III MASK	DZB	Substantially Equivalent	Great Lakes Orthodontics, Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.