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Sign in to claim this brandDentaurum
US
Last updated May 23, 2026
What Dentaurum makes
Dentaurum manufactures dental materials and orthodontic hardware, including ceramic fabrication materials for dental appliances, metal and ceramic orthodontic brackets, metal bands, archwires, and bonded palate expanders. Their portfolio also covers orthodontic wires and screw-based expanders, designed for fixed dental alignment and expansion treatments.
The company’s devices are classified as Class I or Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Dentaurum 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 Dentaurum manufacture?
Dentaurum specializes in dental and orthodontic devices, primarily focusing on materials and hardware used in fixed dental treatments. Their portfolio includes ceramic fabrication materials for dental appliances, metal and ceramic orthodontic brackets, orthodontic bands, archwires, and wires. They also produce bonded palate expanders and screw-based expanders, which are used for teeth alignment and expansion procedures.
Where is Dentaurum based, and what is its primary market?
Dentaurum operates from the United States. While their devices are designed for dental and orthodontic applications, their primary focus is on supplying materials and hardware to dental professionals globally, including the US market where they are based.
Which regulatory registries list Dentaurum’s devices?
Dentaurum’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products under FDA regulations, ensuring transparency and traceability for healthcare providers and regulators.
How are Dentaurum’s devices classified under FDA regulations?
Dentaurum’s devices fall under two classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific device type and its intended use.
What distinguishes Dentaurum’s orthodontic products from others in the market?
Dentaurum’s orthodontic products are distinguished by their diverse material offerings, including both ceramic and metal components. Their ceramic fabrication materials, like ceraMotion®, are designed for aesthetic applications where natural tooth appearance is critical, while their metal brackets and wires, such as remanium® and equilibrium®, provide durability and precision for alignment treatments. This range caters to different clinical needs, from cosmetic to functional orthodontics.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (5631)
Page 8 of 113| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| dentaform® | 881-207-00 | FDA UDI | Class I | Active |
| Fascination® | 700-030-24 | FDA UDI | Class I | Unknown |
| remanium® | 766-767-00 | FDA UDI | Class I | Active |
| remanium® | 728-023-00 | FDA UDI | Class I | Active |
| ceraMotion® | 255-013-05 | FDA UDI | Class II | Active |
| dentaform® | 879-319-18 | FDA UDI | Class I | Active |
| discovery® | 722-101-34 | FDA UDI | Class I | Active |
| ceraMotion® | 252-503-03 | FDA UDI | Class II | Active |
| Fascination® | 700-058-00 | FDA UDI | Class I | Unknown |
| ceraMotion® | 251-253-20 | FDA UDI | Class II | Active |
| remaloy® | 528-090-00 | FDA UDI | Class I | Active |
| ceraMotion® | 250-062-40 | FDA UDI | Class II | Active |
| dentaform® | 878-009-22 | FDA UDI | Class I | Unknown |
| dentaform® | 885-309-22 | FDA UDI | Class I | Active |
| equilibrium® | 790-228-02 | FDA UDI | Class I | Unknown |
| equilibrium® | 790-263-02 | FDA UDI | Class I | Unknown |
| Carmen® | 262-443-60 | FDA UDI | Class II | Unknown |
| ceraMotion® | 252-286-20 | FDA UDI | Class II | Active |
| equilibrium® | 722-441-15 | FDA UDI | Class I | Active |
| ceraMotion® | 250-002-40 | FDA UDI | Class II | Active |
| equilibrium® | 722-442-13 | FDA UDI | Class I | Active |
| equilibrium® | 718-502-42 | FDA UDI | Class I | Active |
| Triceram® | 295-154-30 | FDA UDI | Class II | Active |
| Triceram® | 295-270-30 | FDA UDI | Class II | Active |
| ceraMotion® | 251-026-20 | FDA UDI | Class II | Active |
| ceraMotion® | 250-054-20 | FDA UDI | Class II | Active |
| Dentalastics® | 774-000-00 | FDA UDI | Class I | Unknown |
| discovery® | 718-941-45 | FDA UDI | Class I | Active |
| dentaform® | 885-329-22 | FDA UDI | Class I | Active |
| Fascination® | 700-041-00 | FDA UDI | Class I | Unknown |
| rematitan® | 766-015-00 | FDA UDI | Class I | Active |
| dentaform® | 881-232-00 | FDA UDI | Class I | Active |
| dentaform® | 884-335-22 | FDA UDI | Class I | Active |
| dentaform® | 889-064-00 | FDA UDI | Class I | Active |
| tomas® | 302-210-10 | FDA UDI | Class II | Active |
| tomas® | 302-021-10 | FDA UDI | Class II | Active |
| dentaform® | 879-150-00 | FDA UDI | Class I | Active |
| Triceram® | 294-773-30 | FDA UDI | Class II | Active |
| Dentalastics® | 774-563-00 | FDA UDI | Class I | Unknown |
| Triceram® | 293-199-30 | FDA UDI | Class II | Active |
| amda® | 607-181-02 | FDA UDI | Class I | Active |
| Triceram® | 294-222-30 | FDA UDI | Class II | Active |
| Noninium® | 764-022-00 | FDA UDI | Class I | Unknown |
| discovery® | 790-104-00 | FDA UDI | Class I | Active |
| dentaform® | 878-017-18 | FDA UDI | Class I | Unknown |
| Triceram® | 295-310-30 | FDA UDI | Class II | Active |
| Carmen® | 264-214-60 | FDA UDI | Class II | Unknown |
| Carmen® | 262-432-60 | FDA UDI | Class II | Unknown |
| ceraMotion® | 252-800-45 | FDA UDI | Class II | Active |
| Carmen® | 264-112-30 | FDA UDI | Class II | Unknown |
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