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Great Lakes Dental Technologies

United States·US-MF-000003408

Last updated September 18, 2026

What Great Lakes Dental Technologies makes

Great Lakes Dental Technologies manufactures dental restorative materials, including unfilled resin in various tooth shades and colors, such as acrylic and polymer-based formulations like Biocryl and Magicryl II. The company also produces reusable dental impression trays, reusable mouthguards, orthodontic wires, and extraoral headgear for orthodontic treatment. Additionally, it supplies denture cleansers, including kits like Dentasoak, designed for long-term use.

The company’s products are regulated under both Class I and Class II medical device classifications, depending on the specific application. These devices are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 200, Cooper Avenue, Tonawanda, United States
Website: www.greatlakesdentaltech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Daniel Warf
EUDAMED SRN: US-MF-000003408
FDA FEI Number: —
DUNS Number: —

Catalogue (228)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Bite Registration Wax	260-034	EUDAMEDFDA UDI	Class I	Active
Dental Impression Trays	255-021	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-111	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-100	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-126	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-028	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-406	EUDAMEDFDA UDI	Class I	Active
NOLA Dryfield System	300-401	EUDAMEDFDA UDI	Class I	Active
Dental Impression Trays	255-022	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-125	EUDAMEDFDA UDI	Class I	Active
Bite Registration Wax	260-033	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-304	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-629	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-102	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-614	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-103	EUDAMEDFDA UDI	Class I	Active
Mouthguard Preformed	191-022	EUDAMEDFDA UDI	Class I	Active
Mouthguard Preformed	191-023	EUDAMEDFDA UDI	Class I	Active
Mouthguard Preformed	191-026	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-105	EUDAMEDFDA UDI	Class I	Active
Dental Impression Trays	056-033	EUDAMEDFDA UDI	Class I	Active
NOLA Dryfield System	300-400	EUDAMEDFDA UDI	Class I	Active
Dental Impression Trays	255-025	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-114	EUDAMEDFDA UDI	Class I	Active
Dental Impression Trays	056-032	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-102	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-101	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-632	EUDAMEDFDA UDI	Class I	Active

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