Orthofx
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Orthofx is a medical device manufacturer, with 14 devices listed in FDA GUDID (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 14
Registry facts
- Registries
- FDA GUDID 14
- Device classes
- FDA Class II 7
- FDA Class I 5
- Identifiers
- DUNS 033755180
What Orthofx makes
OrthoFX manufactures orthodontic progressive aligners designed for at-home teeth alignment, including custom-fit aligners like the OrthoFX Aligner and NiTime Aligner. The company also produces dental impression materials and kits, such as single-use impression trays and wax-based materials, alongside orthodontic retainers and teeth whitening kits for consumer use. These products are intended for use in both professional and at-home dental applications, including initial scans, retainer fabrication, and cosmetic treatments.
OrthoFX’s devices are regulated under the FDA’s classification system, with products falling into Class I and Class II categories depending on their intended use and risk level. The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States, adhering to domestic regulatory requirements for dental and orthodontic products.
Catalogue
Search and filter all 14 devicesCompany details
- DUNS number
- 033755180
- Phone
- 415-936-0006
Frequently asked questions
How many devices does ORTHOFX have in the registry?
The registry currently lists 14 devices for ORTHOFX. Devices recorded under merged duplicate company entries are counted once.
Which registries list ORTHOFX's devices?
Among its 14 most recently registered devices, ORTHOFX has devices listed in FDA GUDID (14 devices).
What risk classes do ORTHOFX's devices fall under?
Among its 14 most recently registered devices, the classes recorded for ORTHOFX's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from ORTHOFX in the registry?
The most recently registered devices listed for ORTHOFX include OrthoFX Home Impression Kit HIK1-rev, OrthoFX FXTetra, Glo Science 6HPGT-rev and OrthoFX Aligner 019.