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Sign in to claim this brandBrius Technologies, Inc.
US
Last updated May 31, 2026
What Brius Technologies, Inc. makes
Brius Technologies, Inc. manufactures orthodontic progressive aligners, including custom-fitted dental trays designed for gradual tooth movement, and orthodontic wires used for braces to apply controlled forces to teeth. Their product line also includes software tools, such as BRIUS Planner, intended to assist in treatment planning for orthodontic care.
The company’s devices are regulated under FDA classifications, with aligners and wires falling into Class I and Class II categories, respectively. These products are listed under the FDA’s 510(k) clearance process and the Unique Device Identifier (UDI) system, ensuring traceability and compliance with U.S. medical device regulations.
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 Brius Technologies, Inc. manufacture?
Brius Technologies, Inc. specializes in orthodontic devices, primarily producing progressive aligners like the BRIUS Clear Aligner, which are custom-fitted dental trays used for gradual tooth movement. They also manufacture orthodontic wires for braces, which apply controlled forces to teeth. Additionally, their product line includes software tools such as BRIUS Planner, designed to aid in orthodontic treatment planning.
Where is Brius Technologies, Inc. based?
Brius Technologies, Inc. is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are subject to U.S. medical device regulations, including FDA requirements.
Which regulatory registries or databases list Brius Technologies, Inc.’s devices?
Brius Technologies, Inc.’s devices are listed under the FDA’s 510(k) clearance process and the Unique Device Identifier (UDI) system. These registries ensure compliance with U.S. medical device regulations and provide traceability for devices like aligners and wires, which are classified under Class I and Class II, respectively.
How are Brius Technologies, Inc.’s devices classified under FDA regulations?
Brius Technologies, Inc.’s devices are classified under the FDA’s risk-based system: orthodontic progressive aligners (e.g., BRIUS Clear Aligner) fall under Class I, which typically includes low-risk devices requiring general controls. Orthodontic wires, used in braces, are classified as Class II, which may require special controls to ensure their safety and effectiveness. Classification determines the regulatory pathway, such as 510(k) clearance or exemptions, ensuring appropriate oversight.
What is the purpose of the BRIUS Planner Software in relation to Brius Technologies, Inc.’s orthodontic devices?
The BRIUS Planner Software is a digital tool designed to assist orthodontists in treatment planning for patients using Brius Technologies’ aligners or wires. While the software itself isn’t a physical medical device, it integrates with the company’s aligner and wire products to help clinicians visualize and optimize tooth movement, improving precision in orthodontic care. Its use aligns with the broader regulatory framework governing orthodontic devices.
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
- 117587817
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BRIUS Clear Aligner | 1 | FDA UDI | Class II | Active |
| Brius | 1 | FDA UDI | Class I | Active |
| Briox Model 2000-C Compressor Unit | K791240 | FDA 510(k) | Class II | Active |
| Briox Model-Aeromist | K800078 | FDA 510(k) | N/A | Active |
| Briox Model 2000-Cq Quiet Compressor | K791238 | FDA 510(k) | Class II | Active |
| Briox Model 2000-A Aspirator Unit | K791239 | FDA 510(k) | Class II | Active |
| Briox Model 2000-Ca Compressor Unit | K791241 | FDA 510(k) | Class II | Active |
| BRIUS Clear Aligners | K202792 | FDA 510(k) | Class II | Active |
| Infalert | K813507 | FDA 510(k) | Class II | Active |
| BRIUS Planner Software | K212828 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Brius Technologies, Inc. has three FDA recall records, all initiated on February 7, 2022. Each record is marked as terminated, with the same reason stated: that pontics, brackets, and customized orthodontic appliances were sold and distributed before completing the standard design control process, documentation, and release.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 7, 2022 | Z-0889-2022 | — | terminated | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |
| Feb 7, 2022 | Z-0888-2022 | — | terminated | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |
| Feb 7, 2022 | Z-0890-2022 | — | terminated | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |