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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 4 of 5

Device	Model / Reference	Registries	Class	Status
2oz Neon Red Powder	045-023	FDA UDI	Class II	Active
Neon Yellow Powder Only 1lb	045-028	FDA UDI	Class II	Active
1lb Purple Sunset Tropical Ton	045-083	FDA UDI	Class II	Active
Glo Ezkey Pkg/10 *o	140-020	FDA UDI	Class I	Active
Kit-Acrylic Galaxy Glitter	045-100	FDA UDI	Class II	Active
Titanium Molybdenum Wire	265-102	FDA UDI	Class I	Active
Extraoral Headgear	300-122	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-308	EUDAMEDFDA UDI	Class I	Active
Mouthguard Preformed	191-027	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-123	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-627	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-630	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-106	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-104	EUDAMEDFDA UDI	Class I	Active
Bite Registration Wax	260-035	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-414	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-103	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-612	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-626	EUDAMEDFDA UDI	Class I	Active
Bite Registration Wax	260-031	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-121	EUDAMEDFDA UDI	Class I	Active
Dental Impression Trays	056-025	EUDAMEDFDA UDI	Class I	Active
Dental Impression Trays	056-024	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-309	EUDAMEDFDA UDI	Class I	Active
Bite Registration Wax	260-032	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-307	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-110	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-202	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-125	EUDAMEDFDA UDI	Class I	Active
Dental Impression Trays	255-023	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-306	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-108	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-104	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-101	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-121	EUDAMEDFDA UDI	Class I	Active
Mouthguard Preformed	191-025	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-109	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-100	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	300-107	EUDAMEDFDA UDI	Class I	Active
Dental Impression Trays	056-023	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-107	EUDAMEDFDA UDI	Class I	Active
Mouthguard Preformed	191-021	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-105	EUDAMEDFDA UDI	Class I	Active
Mouthguard Preformed	191-024	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-029	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-628	EUDAMEDFDA UDI	Class I	Active
Great Lakes NOLA Dry Field System	300-631	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-106	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-112	EUDAMEDFDA UDI	Class I	Active
Extraoral Headgear	155-113	EUDAMEDFDA UDI	Class I	Active

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