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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 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 1-Lb Orange Magicryl Ii Powder | 045-136 | FDA UDI | Class II | Active |
| Biocryl Ice 5# Kit | 047-002 | FDA UDI | Class II | Active |
| BIOCRYL ICE 8oz MONOMER | 047-004 | FDA UDI | Class II | Active |
| Std-Adaptable Class Iii Mask | 155-122 | FDA UDI | Class II | Active |
| 25lb Clear Polymer | 040-018 | FDA UDI | Class II | Active |
| 1-Lb Solar Silver Galaxy | 045-104 | FDA UDI | Class II | Active |
| 2oz Violet Rainbow Monomer | 045-004 | FDA UDI | Class II | Active |
| 2oz VIOLET DYE CONCENTRATE | 045-035 | FDA UDI | Class II | Active |
| 4oz POLARIS PURPLE GALAXY | 045-107 | FDA UDI | Class II | Active |
| 4oz Red Dye Concentrate | 045-030 | FDA UDI | Class II | Active |
| 8 Oz Blue Monomer Biocryl Resi | 040-026 | FDA UDI | Class II | Active |
| 4oz Licorice Contemporary | 045-044 | FDA UDI | Class II | Active |
| 1lb Neon Blue Powder | 045-027 | FDA UDI | Class II | Active |
| 1lb Neon Red Powder | 045-017 | FDA UDI | Class II | Active |
| 4oz RED MAGICRYL II POWDER | 045-137 | FDA UDI | Class II | Active |
| 4oz BLACK MAGICRYL II POWDER | 045-131 | FDA UDI | Class II | Active |
| Qt Blue Monomer Biocryl Resin | 040-049 | FDA UDI | Class II | Active |
| 4oz ROCKET RED GALAXY GLITTER | 045-115 | FDA UDI | Class II | Active |
| 1lb Neon Green Powder | 045-029 | FDA UDI | Class II | Active |
| 1lb Key Lime Green Tropical To | 045-058 | FDA UDI | Class II | Active |
| Velcro Headcap | 155-159 | FDA UDI | Class II | Active |
| 8oz ORANGE RAINBOW MONOMER | 045-093 | FDA UDI | Class II | Active |
| Fast-White Resin Kit | 040-004 | FDA UDI | Class II | Active |
| 1-Lb Orbit Orange Galaxy | 045-110 | FDA UDI | Class II | Active |
| 1-Lb Red Magicryl Ii Powder | 045-138 | FDA UDI | Class II | Active |
| 4oz Banana Yellow Tropical Ton | 045-051 | FDA UDI | Class II | Active |
| 1qt Pink Monomer Biocryl Resin | 040-034 | FDA UDI | Class II | Active |
| 2oz Neon Glow Powder | 045-020 | FDA UDI | Class II | Active |
| Dentasoak Kit (3 Months) | 235-022 | FDA UDI | Class I | Active |
| Blue Tone Kit Biocryl Resin | 040-014 | FDA UDI | Class II | Active |
| 1lb Apple Red Contemporary | 045-084 | FDA UDI | Class II | Active |
| 2oz NEON TEAL POWDER | 045-012 | FDA UDI | Class II | Active |
| 1lb Pink Polymer Biocryl Resin | 040-020 | FDA UDI | Class II | Active |
| 2oz Neon Yellow Powder | 045-025 | FDA UDI | Class II | Active |
| 1qt Splint Monomer | 040-002 | FDA UDI | Class II | Active |
| 25lb Splint Polymer Clear | 040-005 | FDA UDI | Class II | Active |
| 1lb Ocean Blue Tropical Tones | 045-055 | FDA UDI | Class II | Active |
| 2oz YELLOW DYE CONCENTRATE | 045-032 | FDA UDI | Class II | Active |
| Variflex 1 Lb Powder Only *o | 046-004 | FDA UDI | Class II | Active |
| 1qt Clear Monomer Biocryl Resi | 040-033 | FDA UDI | Class II | Active |
| 2oz RED RAINBOW RESIN | 045-002 | FDA UDI | Class II | Active |
| 1lb Kit Splint Resin *o | 040-008 | FDA UDI | Class II | Active |
| Try-Me Dentasoak Kit | 235-024 | FDA UDI | Class I | Active |
| 1-Lb Black Magicryl Ii Powder | 045-132 | FDA UDI | Class II | Active |
| 4oz Snow White Contemporary | 045-045 | FDA UDI | Class II | Active |
| 2oz BROWN DYE CONCENTRATE | 045-037 | FDA UDI | Class II | Active |
| 5lb Splint Polymer | 040-003 | FDA UDI | Class II | Active |
| 1lb Lava Red Tropical Tones | 045-056 | FDA UDI | Class II | Active |
| Titanium Molybdenum Wire | 265-101 | FDA UDI | Class I | Active |
| The George Gauge Kit | 056-050 | FDA UDI | Class I | Active |
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