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Sign in to claim this brandORTHO TECHNOLOGY, INC.
US
Last updated May 23, 2026
What ORTHO TECHNOLOGY, INC. makes
Ortho Technology, Inc. manufactures orthodontic appliances, including metal bands, archwires, and brackets made of metal, ceramic, and single-use plastic. Their portfolio also covers inter-bracket elastic chains, inter-arch elastic bands, and orthodontic tubes, primarily under the TruFit 2.0 and Reflections brands.
These devices are regulated as Class I or Class II under the FDA’s UDI program and are listed in the FDA’s database. The company is based in 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 Ortho Technology, Inc. manufacture?
Ortho Technology, Inc. specializes in orthodontic devices used in dental treatments. Their product range includes orthodontic metal bands, archwires, and brackets made from metal, ceramic, and single-use plastic. They also produce inter-bracket elastic chains, inter-arch elastic bands, and orthodontic tubes. These devices are designed to aid in straightening teeth and aligning the jaw, commonly used by orthodontists and dentists.
Where is Ortho Technology, Inc. based?
Ortho Technology, Inc. is headquartered in the United States. Their location is relevant for regulatory compliance and distribution, as their devices are subject to U.S. medical device regulations.
Which regulatory registries or databases list Ortho Technology, Inc.’s devices?
Ortho Technology, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, regulators, and patients by providing standardized identification for their orthodontic products.
How are Ortho Technology, Inc.’s devices classified under medical device regulations?
Ortho Technology, Inc.’s devices fall under two regulatory classifications: Class I and Class II. Class I devices are generally considered low-risk, such as some orthodontic brackets, while Class II devices, like certain archwires or elastic chains, may pose higher risks and require additional controls to ensure safety and effectiveness. The classification determines the regulatory scrutiny and requirements each device must meet.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 781772017
Catalogue (8674)
Page 15 of 174| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TruFit 2.0 | 493-12-1682-330-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-21-4620-330-3 | FDA UDI | Class I | Active |
| PixSure Perfect® | 32805 | FDA UDI | Class I | Active |
| X7 | 400-110 | FDA UDI | Class I | Unknown |
| TruFit 2.0 | 493-11-1620-425-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 491-22-3610-310-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 491-11-2672-360-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-11-2610-315-3 | FDA UDI | Class I | Active |
| Lotus Plus DS | LPAM22-023 | FDA UDI | Class I | Unknown |
| TruFit 2.0 | 493-21-4610-335-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-91-3620-295-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-92-4620-400-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 491-11-2672-420-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 491-11-2610-425-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 491-11-1672-370-3 | FDA UDI | Class I | Active |
| Bionic | B22-234 | FDA UDI | Class I | Active |
| TruFlex | D6001-018 | FDA UDI | Class I | Active |
| Reflections | REF-621 | FDA UDI | Class II | Unknown |
| TruFit 2.0 | 491-11-1620-350-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 491-92-3610-420-3 | FDA UDI | Class I | Active |
| Lotus Plus DS | LPAD22-071 | FDA UDI | Class I | Unknown |
| TruFit 2.0 | 491-12-1671-440-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-22-1672-425-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-22-1671-385-3 | FDA UDI | Class I | Active |
| Pure | S18030 | FDA UDI | Class II | Active |
| Avalon | A22-051 | FDA UDI | Class II | Active |
| Pinnacle | 360-22-4400 | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-11-1620-345-3 | FDA UDI | Class I | Active |
| Bionic | B18-761 | FDA UDI | Class I | Active |
| Votion | 350-92-3522 | FDA UDI | Class I | Active |
| TruFit 2.0 | 491-11-2620-380-3 | FDA UDI | Class I | Active |
| PixSure Perfect® | 32701 | FDA UDI | Class I | Active |
| OrthoFlex | COM-031-C | FDA UDI | Class II | Unknown |
| TruFit 2.0 | 491-92-3620-435-3 | FDA UDI | Class I | Active |
| Power Sticks | 404-007S | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-21-3720-315-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-92-3631-295-3 | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-12-1682-395-3 | FDA UDI | Class I | Active |
| TruForce | TLP-642 | FDA UDI | Class I | Active |
| Avalon | A22-002 | FDA UDI | Class II | Unknown |
| Lotus Plus DS | LPPM18-071 | FDA UDI | Class I | Unknown |
| TruFit 2.0 | 493-91-3691-335-3 | FDA UDI | Class I | Active |
| TruForce | 8000-109* | FDA UDI | Class I | Active |
| TruFlex | 6000-001 | FDA UDI | Class I | Active |
| TruFit 2.0 | 493-21-4620-410-3 | FDA UDI | Class I | Active |
| OrthoFlex | CM22-4000C | FDA UDI | Class II | Unknown |
| Pure | S18051 | FDA UDI | Class II | Active |
| Lotus Plus DS | LPPM22-062 | FDA UDI | Class I | Unknown |
| Sensation M | 390-12-2910 | FDA UDI | Class I | Unknown |
| OrthoFlex | COM-853-C | FDA UDI | Class II | Unknown |
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