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Sign in to claim this brandPro3Dure Medical
US
Last updated May 23, 2026
What Pro3Dure Medical makes
Pro3Dure Medical produces custom dental and auditory devices, including custom-made earmoulds, dental appliances fabricated from resin, temporary crown/bridge resins, removable occlusal splints, dental base plates, and artificial resin teeth. Their portfolio also covers materials for dental impression-taking and custom-fit mouthguards, as well as impression materials for earmould fabrication.
The company’s devices are regulated under FDA’s classification system as Class I, Class II, or Unclassified (U), with products listed in the FDA’s Unique Device Identifier (UDI) database. Pro3Dure Medical operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Pro3Dure Medical manufacture?
Pro3Dure Medical specializes in custom dental and auditory devices. Their portfolio includes custom-made earmoulds, materials for earmould impressions, dental appliances like removable occlusal splints and base plates, temporary crown/bridge resins, custom-fit mouthguards, and artificial resin teeth. These products are designed for precision applications in both dental and auditory care.
Where is Pro3Dure Medical based?
Pro3Dure Medical is headquartered in the United States. Their operations and product development are conducted within the country, aligning with U.S. regulatory standards for medical devices.
Which regulatory registries list Pro3Dure Medical’s devices?
Pro3Dure Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for their products under FDA oversight.
How are Pro3Dure Medical’s devices classified under FDA regulations?
Pro3Dure Medical’s devices fall under three classification categories: Class I (generally low-risk), Class II (moderate-risk with special controls), and Unclassified (U). Classification depends on factors like intended use, risk level, and regulatory history, ensuring appropriate oversight for each product.
Why do some of Pro3Dure Medical’s devices appear multiple times in the example list?
The repeated device names in the example list reflect variations in product formulations or packaging (e.g., powder vs. liquid forms) or slight modifications for specific applications. Each entry represents a distinct entry in the UDI database, accounting for differences in composition or intended use without implying duplication of identical devices.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (315)
Page 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PRO3DURE GR-10 guide | 1kg - clear transparent 405nm | FDA UDI | U | Active |
| audioprint INR-1 | 1000 g bottle ; Light Blue Translucent | FDA UDI | Class I | Active |
| PRO3DURE GR-14.2 denture HI | 1kg - Orange-Pink | FDA UDI | Class II | Active |
| printodent GR-21.1 Try-In | 1kg ; Color:A2 | FDA UDI | Class I | Active |
| audioprint INR-1 | 1000 g bottle ; Smoke Grey | FDA UDI | Class I | Active |
| otosil ES-1.1 | Shore 60 / 8 double cartridges of 2 x 24 ml - white opaque | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 500 g - tan opaque | FDA UDI | Class I | Active |
| PRO3DURE GR-17.1 temporary lt | 500g - A2 | FDA UDI | Class II | Active |
| Pro3dure Gr-10 | 1kg - purple transparent | FDA UDI | Class I | Active |
| UCAN Print Base | 1000g ; color 33 | FDA UDI | Class II | Active |
| PRO3DURE THERMEO Blank | color A3, height 20 mm | FDA UDI | U | Active |
| otosil ES-1.1 | Shore 60 / 8 double cartridges of 2 x 24 ml - neon-yellow opaque | EUDAMEDFDA UDI | Class I | Active |
| Pro3dure Pr-1 | 250 g - light red | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 250 g - black opaque | FDA UDI | Class I | Active |
| GR Resin System MSI | K231775 | FDA 510(k) | U | Active |
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