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Sign in to claim this brandGreat 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
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Daniel Warf
- EUDAMED SRN
- US-MF-000003408
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (228)
Page 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 4oz Apple Red Contemporary | 045-038 | FDA UDI | Class II | Active |
| 5lb Clear Kit Biocryl Resin | 040-031 | FDA UDI | Class II | Active |
| #62 Tooth Shade 1# (acrylic) | 040-012 | FDA UDI | Class II | Active |
| 1-Lb Rocket Red Galaxy Glitter | 045-116 | FDA UDI | Class II | Active |
| 1-Lb Astro Aqua Galaxy Glitter | 045-106 | FDA UDI | Class II | Active |
| 2oz Neon Orange Powder | 045-022 | FDA UDI | Class II | Active |
| 1-Lb Meteor Multi Galaxy | 045-112 | FDA UDI | Class II | Active |
| 1lb Clear Polymer Biocryl | 040-017 | FDA UDI | Class II | Active |
| 2oz Neon Blue Powder | 045-024 | FDA UDI | Class II | Active |
| Dentasoak Kit-No Cup(3 Months) | 235-026 | FDA UDI | Class I | Active |
| 1-Lb Yellow Magicryl Ii Powder | 045-134 | FDA UDI | Class II | Active |
| 8oz Red Rainbow Monomer | 045-006 | FDA UDI | Class II | Active |
| Biocryl Ice 1qt Monomer | 047-006 | FDA UDI | Class II | Active |
| 1lb Tidewater Teal Tropical | 045-081 | FDA UDI | Class II | Active |
| VARIFLEX 8oz MONOMER ONLY *O | 046-003 | FDA UDI | Class II | Active |
| 5lb Kit Splint Resin Clear *o | 040-001 | FDA UDI | Class II | Active |
| 100lb Clear Polymer Biocryl | 040-019 | FDA UDI | Class II | Active |
| 2oz Neon Pink Powder | 045-021 | FDA UDI | Class II | Active |
| Neon Glow Assorted Resin Kit | 045-011 | FDA UDI | Class II | Active |
| Titanium Molybdenum Wire | 265-100 | FDA UDI | Class I | Active |
| Magicryl Ii Kit | 045-130 | FDA UDI | Class II | Active |
| 2oz GREEN DYE CONCENTRATE | 045-033 | FDA UDI | Class II | Active |
| 8oz Pink Monomer Biocryl Resin | 040-024 | FDA UDI | Class II | Active |
| 2oz BLACK DYE CONCENTRATE | 045-034 | FDA UDI | Class II | Active |
| 4oz TEAL MAGICRYL II POWDER | 045-141 | FDA UDI | Class II | Active |
| 8oz Blue Rainbow Monomer | 045-007 | FDA UDI | Class II | Active |
| 1lb Neon Glow Powder | 045-019 | FDA UDI | Class II | Active |
| 4oz BLASTOFF BLUE GALAXY | 045-101 | FDA UDI | Class II | Active |
| 4oz Lava Red Tropical Tones | 045-050 | FDA UDI | Class II | Active |
| 4oz Paradise Pink Tropical Ton | 045-054 | FDA UDI | Class II | Active |
| Biocryl X 1# Kit | 048-001 | FDA UDI | Class II | Active |
| 1lb Fast White Polymer | 040-006 | FDA UDI | Class II | Active |
| 4oz YELLOW MAGICRYL II POWDER | 045-133 | FDA UDI | Class II | Active |
| 2oz Yellow Rainbow Monomer | 045-005 | FDA UDI | Class II | Active |
| Langlade Mini Chin Cup | 155-118 | FDA UDI | Class II | Active |
| 4oz Mango Orange Tropical Tone | 045-053 | FDA UDI | Class II | Active |
| 8oz Splint (clear) Monomer | 040-009 | FDA UDI | Class II | Active |
| 8oz VIOLET RAINBOW MONOMER | 045-086 | FDA UDI | Class II | Active |
| 4oz GALAXY GOLD GLITTER | 045-113 | FDA UDI | Class II | Active |
| 2oz AMBER DYE CONCENTRATE | 045-036 | FDA UDI | Class II | Active |
| 1-Lb Blue Magicryl Ii Powder | 045-140 | FDA UDI | Class II | Active |
| STARDUST 4oz | 045-062 | FDA UDI | Class II | Active |
| 1lb Blueberry Contemporary | 045-089 | FDA UDI | Class II | Active |
| 1lb Banana Yellow Tropical Ton | 045-057 | FDA UDI | Class II | Active |
| 1-Lb Teal Magicryl Ii Powder | 045-142 | FDA UDI | Class II | Active |
| 1-Lb Blastoff Blue Galaxy | 045-102 | FDA UDI | Class II | Active |
| 4oz Lime Contemporary Powder | 045-039 | FDA UDI | Class II | Active |
| 8oz Clear Monomer Biocryl Resi | 040-022 | FDA UDI | Class II | Active |
| 2oz Black Rainbow Monomer | 045-010 | FDA UDI | Class II | Active |
| Pink Tone Kit Biocryl Resin | 040-013 | FDA UDI | Class II | Active |
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