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Sign in to claim this brandzebris MEDICAL GmbH
US
Last updated May 24, 2026
What zebris MEDICAL GmbH makes
The company produces orthodontic and dental diagnostic devices, including facebow attachments such as the Para-occlusal Attachment with Lip Arch and Support Surface, as well as bite analysis tools like the Bite Fork Type SI and Alignment Fork. It also manufactures gait analysis systems, such as the FDM-3 System and FDM-SX System, which assess movement and biomechanics. Additional products include the ARCUSdigma 3 USB for dental occlusion analysis and the PlaneAnalyser II for occlusal plane evaluation, both available in USB-compatible versions.
These devices are classified under Class I by regulatory standards and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates with a US presence, adhering to applicable medical device regulations in the country.
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 zebris MEDICAL GmbH manufacture?
zebris MEDICAL GmbH specializes in orthodontic and dental diagnostic devices, such as facebow attachments (e.g., Para-occlusal Attachment with Lip Arch or Support Surface) and bite analysis tools (e.g., Bite Fork Type SI or Alignment Fork). Additionally, the company produces gait analysis systems (e.g., FDM-3 System or FDM-SX System) designed to evaluate movement and biomechanics. These devices support dental and orthodontic assessments, as well as biomechanical evaluations in clinical settings.
Where is zebris MEDICAL GmbH based, and how does this affect its regulatory compliance?
zebris MEDICAL GmbH has a presence in the United States, where it operates under applicable medical device regulations. Since its devices are classified as Class I under regulatory standards, they are subject to general controls but may still require compliance with FDA requirements, including registration, listing, and UDI reporting. The company’s US operations ensure adherence to local regulatory frameworks for device authorization.
Which regulatory registries list zebris MEDICAL GmbH’s devices?
zebris MEDICAL GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify device details, including manufacturer information and classification. Listing in the UDI database is a key requirement for Class I devices in the US.
How are zebris MEDICAL GmbH’s devices classified under regulatory standards?
zebris MEDICAL GmbH’s devices are classified as Class I under regulatory standards. This classification typically applies to low-risk devices that pose minimal potential harm to patients, such as diagnostic attachments, bite analysis tools, and gait analysis systems. Class I devices generally require fewer regulatory controls but must still comply with basic safety and performance requirements, including proper labeling and manufacturing practices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- noraxon.com
- —
- —
- [email protected]
- Phone
- 800-364-8985
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 328971791
Catalogue (55)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fdm-3 | 01243030 | FDA UDI | Class I | Active |
| ARCUSdigma 3 USB | 01170041 | FDA UDI | Class I | Active |
| Para-occlusal Attachment with Lip Arch AG | 01960251 | FDA UDI | Class I | Active |
| Para-occlusal Attachment with Support Surface | 01960255 | FDA UDI | Class I | Active |
| PlaneAnalyser II | 01170071 | FDA UDI | Class I | Active |
| FDM-SX System | 01543005 | FDA UDI | Class I | Active |
| JMA Optic | 01570011 | FDA UDI | Class I | Active |
| JMA Optic Schütz | 01570020 | FDA UDI | Class I | Unknown |
| zebris for ceramill USB-L | 01570052 | FDA UDI | Class I | Active |
| SICAT JMT blue | 01570030 | FDA UDI | Class I | Unknown |
| FDM-3 System | 01543030 | FDA UDI | Class I | Active |
| Bite Fork Type SI / Fusion Bite | 01960330 | FDA UDI | Class I | Active |
| Alignment Fork | 01960430 | FDA UDI | Class I | Active |
| PlaneAnalyser II USB | 01170072 | FDA UDI | Class I | Active |
| Tizian JMA Optic | 01170021 | FDA UDI | Class I | Active |
| Para-occlusal Attachment | 01960260 | FDA UDI | Class I | Active |
| Para-occlusal Attachment with Support Surface AG | 01960256 | FDA UDI | Class I | Active |
| zebris for ceramill USB | 01170051 | FDA UDI | Class I | Active |
| Bite Fork UN | 01960360 | FDA UDI | Class I | Active |
| Tizian JMA Optic USB | 01170023 | FDA UDI | Class I | Active |
| ARCUSdigma 3 | 01170040 | FDA UDI | Class I | Active |
| Plane Analyse DigiPro | 01570070 | FDA UDI | Class I | Unknown |
| ARCUSdigma 3 USB | 01570041 | FDA UDI | Class I | Active |
| Bite Fork Adapter / Fusion Bite Adapter | 01960400 | FDA UDI | Class I | Active |
| zebris for ceramill | 01170050 | FDA UDI | Class I | Active |
| Tizian JMA Optic | 01570021 | FDA UDI | Class I | Active |
| zebris for ceramill USB | 01570051 | FDA UDI | Class I | Active |
| JMA Optic | 01170011 | FDA UDI | Class I | Active |
| PlaneAnalyser II USB | 01570072 | FDA UDI | Class I | Active |
| JMA Optic USB-L | 01570013 | FDA UDI | Class I | Active |
| Bite Fork Adapter UN | 01960420 | FDA UDI | Class I | Active |
| JMA Optic | 01170010 | FDA UDI | Class I | Active |
| Fdm-1.5 | 01243015 | FDA UDI | Class I | Active |
| Fdm-S | 01243010 | FDA UDI | Class I | Active |
| Plane Analyse DigiPro | 01170070 | FDA UDI | Class I | Unknown |
| Para-occlusal Attachment with Lip Arch | 01960250 | FDA UDI | Class I | Active |
| Inductive Charger PlaneAnalyser II | 01570570 | FDA UDI | Class I | Active |
| Bite Fork PS1 | 01960341 | FDA UDI | Class I | Active |
| zebris for ceramill | 01570050 | FDA UDI | Class I | Active |
| Inductive Charger zebris for ceramill | 01570550 | FDA UDI | Class I | Active |
| Tizian JMA Optic USB | 01570023 | FDA UDI | Class I | Active |
| Inductive Charger Tizian JMA-Optic | 01570520 | FDA UDI | Class I | Active |
| FDM-S System | 01543010 | FDA UDI | Class I | Active |
| FDM-1.5 System | 01543015 | FDA UDI | Class I | Active |
| SICAT JMA blue | 01170030 | FDA UDI | Class I | Unknown |
| ARCUSdigma 3 | 01570040 | FDA UDI | Class I | Active |
| FDM-2 System | 01543020 | FDA UDI | Class I | Active |
| Fdm-2 | 01243020 | FDA UDI | Class I | Active |
| Inductive Charger ARCUSdigma III | 01570540 | FDA UDI | Class I | Active |
| JMA Optic Schütz | 01170020 | FDA UDI | Class I | Unknown |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Zebris Medical Gmbh Isny Baden-Wurttemberg · DE FEI 3004982293