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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 5 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pro3dure Pr-1 | 250 g - amber | FDA UDI | Class I | Active |
| Pro3dure Gr-10 | 1kg - red-transparent | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 250 g - pink opaque | FDA UDI | Class I | Active |
| Pro3dure L-1 | 100 g - lightblue-transparent | FDA UDI | Class I | Active |
| PRO3DURE THERMEO Blank | color A2, height 20 mm | FDA UDI | U | Active |
| Pro3dure Gr-10 | 1kg - tan opaque | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 1000 g - reddish transparent | FDA UDI | Class I | Active |
| Pro3dure L-1 | 100 g - green-transparent | FDA UDI | Class I | Active |
| otosil ES-1.1 | Shore 25 / 8 double cartridges of 2 x 24 ml - neon-pink opaque | FDA UDI | Class I | Active |
| PRO3DURE GR-14.2 denture HI | 1kg - Natural Pink | FDA UDI | Class II | Active |
| otosil ES-1.1 | Shore 60 / 8 double cartridges of 2 x 24 ml - reddish transparent | FDA UDI | Class I | Active |
| PRO3DURE GR-22 flex | 500g | FDA UDI | U | Active |
| Pro3dure Gr-19 Oa | 1kg - Clear transparent | FDA UDI | U | Active |
| otosil ES-1.1 | Shore 40 / 8 double cartridges of 2 x 24 ml - neon-orange opaque | FDA UDI | Class I | Active |
| Pro3dure Gr-1 | 1kg - Cocoa brown | FDA UDI | Class I | Active |
| Pro3dure Gr-19 Oa | 500 g - Rose transparent | FDA UDI | U | Active |
| ACRY PRINT RU-001 Temporary | 1000g ; A3 | FDA UDI | Class II | Active |
| PRO3DURE GR-17 temporary | 500g - A2 | FDA UDI | Class II | Active |
| audioprint L-2 FLX | 100 g - Clear Transparent | FDA UDI | Class I | Active |
| printodent GR-19.1 OA I MSI | ocean-blue, 1000g | FDA UDI | Class I | Active |
| Pro3dure Gr-10 | 1kg - smoke grey transparent | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 500 g - green transparent | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 250 g - blue-transparent | FDA UDI | Class I | Active |
| otosil ES-1.1 | Shore 60 / 8 double cartridges of 2 x 24 ml - neon-green opaque | FDA UDI | Class I | Active |
| otosil protect 50 I MSI | neon-pink | FDA UDI | Class I | Active |
| otosil protect 50 I MSI | neon-orange | FDA UDI | Class I | Active |
| Pro3dure L-1 | 250 g - Red Transparent | FDA UDI | Class I | Active |
| audioprint HPR-1 | 1000 g bottle, Red Transparent | FDA UDI | Class I | Active |
| PRO3DURE GR-17 temporary | 500g - A3.5 | FDA UDI | Class II | Active |
| ACRY PRINT RU-001 Temporary | 1000g ; A2 | FDA UDI | Class II | Active |
| Pro3dure Gr-10 | 1kg - clear-transparent B | FDA UDI | Class I | Active |
| Pro3dure L-1 | 100 g - red-transparent | FDA UDI | Class I | Active |
| otosil ES-1.1 | Shore 40 / 8 double cartridges of 2 x 24 ml - neon-pink opaque | FDA UDI | Class I | Active |
| otosil ES-1.1 | Shore 25 / 8 double cartridges of 2 x 24 ml - neon-orange opaque | FDA UDI | Class I | Active |
| Pro3dure Gr-10 | 1kg - red opaque | FDA UDI | Class I | Active |
| PRO3DURE SysTherm PU | SysTherm PU Black | FDA UDI | Class I | Active |
| audioprint INR-1 | 500 g bottle ; red-opaque | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 500 g - beige opaque | FDA UDI | Class I | Active |
| Pro3dure L-1 | 100 g - grey-transparent | FDA UDI | Class I | Active |
| otosil ES-1.1 | Shore 40 / 8 double cartridges of 2 x 24 ml - red opaque | FDA UDI | Class I | Active |
| PRO3DURE GR-1guide | 1kg - clear-transparent | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 500 g - clear transparent | FDA UDI | Class I | Active |
| PRO3DURE GR-17.1 temporary lt | 500g - bleach | FDA UDI | Class II | Active |
| PRO3DURE GR-17.1 temporary lt | 1kg - A2 | FDA UDI | Class II | Active |
| Pro3dure L-1 | 100 g - lightred-transparent | FDA UDI | Class I | Active |
| printodent GR-18.2 IB | 1000g; clear transparent | FDA UDI | Class I | Active |
| ACRY PRINT RU-003 Try-In | 1000g ; A2 | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 500 g - pink opaque | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 1000 g - pink translucent | FDA UDI | Class I | Active |
| Pro3dure Pr-1 | 250 g - blue grotto transparent | FDA UDI | Class I | Active |
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