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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 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 1lb Neon Pink Powder | 045-016 | FDA UDI | Class II | Active |
| 4oz Tidewater Teal Tropical To | 045-080 | FDA UDI | Class II | Active |
| 8oz Yellow Rainbow Monomer | 045-008 | FDA UDI | Class II | Active |
| Dentasoak (1 Month) | 235-023 | FDA UDI | Class I | Active |
| 2oz Blue Rainbow Monomer | 045-003 | FDA UDI | Class II | Active |
| Biocryl Ice 1# Kit | 047-001 | FDA UDI | Class II | Active |
| 2oz Green Rainbow Monomer | 045-009 | FDA UDI | Class II | Active |
| 8oz GREEN RAINBOW MONOMER | 045-087 | FDA UDI | Class II | Active |
| 4oz Blue Dye Concentrate | 045-031 | FDA UDI | Class II | Active |
| 2oz ORANGE RAINBOW RESIN | 045-092 | FDA UDI | Class II | Active |
| Rainbow Resin Kit | 045-001 | FDA UDI | Class II | Active |
| 1lb Snow White Contemporary | 045-047 | FDA UDI | Class II | Active |
| 4oz Lemon Contemporary Powder | 045-043 | FDA UDI | Class II | Active |
| 2oz Neon Green Powder | 045-026 | FDA UDI | Class II | Active |
| George Gauge | 056-022 | FDA UDI | Class I | Unknown |
| Gl Acculight Expansion Key | 140-015 | FDA UDI | Class I | Active |
| Stardust 1-Lb | 045-061 | FDA UDI | Class II | Active |
| Variflex Quart Monomer Only *o | 046-005 | FDA UDI | Class II | Active |
| 4oz ORANGE MAGICRYL II POWDER | 045-135 | FDA UDI | Class II | Active |
| 4oz ASTRO AQUA GALAXY GLITTER | 045-105 | FDA UDI | Class II | Active |
| 5lb Pink Kit Biocryl Resin | 040-030 | FDA UDI | Class II | Active |
| 4oz Key Lime Green Tropical To | 045-052 | FDA UDI | Class II | Active |
| 1lb Mango Orange Tropical Tone | 045-059 | FDA UDI | Class II | Active |
| Contemporary Kit | 045-088 | FDA UDI | Class II | Active |
| 4oz Purple Sunset Tropical Ton | 045-082 | FDA UDI | Class II | Active |
| 1lb Neon Orange Powder | 045-018 | FDA UDI | Class II | Active |
| 4oz Blueberry Contemporary | 045-041 | FDA UDI | Class II | Active |
| Biocryl Ice 1# Polymer | 047-003 | FDA UDI | Class II | Active |
| 4oz BLUE MAGICRYL II POWDER | 045-139 | FDA UDI | Class II | Active |
| 4oz METEOR MULII GALAXY | 045-111 | FDA UDI | Class II | Active |
| Pink Opaque Kit Biocryl Resin | 040-015 | FDA UDI | Class II | Active |
| Clear Kit Biocryl Resin | 040-016 | FDA UDI | Class II | Active |
| 4oz Ocean Blue Tropical Tones | 045-049 | FDA UDI | Class II | Active |
| 1lb Splint Polymer Clear | 040-010 | FDA UDI | Class II | Active |
| 4oz SOLAR SILVER GALAXY | 045-103 | FDA UDI | Class II | Active |
| 4oz Tangerine Contemporary | 045-042 | FDA UDI | Class II | Active |
| 2oz NEON PURPLE POWDER | 045-014 | FDA UDI | Class II | Active |
| 4oz ORBIT ORANGE GALAXY | 045-109 | FDA UDI | Class II | Active |
| Biocryl Ice 5# Polymer | 047-005 | FDA UDI | Class II | Active |
| 1lb Paradise Pink Tropical Ton | 045-060 | FDA UDI | Class II | Active |
| Tropical Tones Assorted Kit | 045-048 | FDA UDI | Class II | Active |
| 1 Lb Neon Teal Powder | 045-013 | FDA UDI | Class II | Active |
| 5lb Clear Polymer | 040-032 | FDA UDI | Class II | Active |
| 8oz BLACK RAINBOW MONOMER | 045-040 | FDA UDI | Class II | Active |
| Variflex Kit 1/2 # *o | 046-002 | FDA UDI | Class II | Active |
| Biocryl Xr 1# Kit | 048-002 | FDA UDI | Class II | Active |
| 1-Lb Polaris Purple Galaxy | 045-108 | FDA UDI | Class II | Active |
| 1lb Licorice Contemporary | 045-046 | FDA UDI | Class II | Active |
| 1 Lb Neon Purple Powder | 045-015 | FDA UDI | Class II | Active |
| Variflex Kit 1# *o | 046-001 | FDA UDI | Class II | Active |
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