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Sign in to claim this brandHelmut Zepf Medizintechnik GmbH
US
Last updated May 24, 2026
What Helmut Zepf Medizintechnik GmbH makes
Helmut Zepf Medizintechnik GmbH manufactures reusable surgical instruments for dental and periodontal procedures, including periosteal elevators, dental elevators for tooth or root extraction, periodontal curettes, and dental surgical probes. Their portfolio also includes reusable scalpels, tooth extraction forceps, hand-held surgical retractors, and instrument transport trolleys designed for clinical workflows.
The company’s devices are classified under Class I in the US and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
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 Helmut Zepf Medizintechnik GmbH manufacture?
Helmut Zepf Medizintechnik GmbH specializes in reusable surgical instruments primarily used in dental and periodontal procedures. Their product range includes periosteal elevators for lifting gum tissue, dental elevators for tooth or root extraction, periodontal curettes for cleaning below the gumline, and dental surgical probes for examining oral tissues. They also produce reusable scalpels, tooth extraction forceps, hand-held surgical retractors, and instrument transport trolleys to streamline clinical workflows.
Where is Helmut Zepf Medizintechnik GmbH based?
The company is based in the United States. This location determines the regulatory framework governing its devices, including compliance with US medical device requirements and classification systems.
Which regulatory registries list Helmut Zepf Medizintechnik GmbH’s devices?
Helmut Zepf Medizintechnik GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices under US jurisdiction, allowing healthcare providers and regulators to identify and verify the devices.
How are Helmut Zepf Medizintechnik GmbH’s devices classified in the US?
The company’s devices fall under Class I classification in the US. This classification applies to low-risk medical devices that pose minimal potential harm to users, such as reusable surgical instruments like elevators, curettes, and retractors. Class I devices typically require general controls (e.g., good manufacturing practices) but may not need pre-market approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zepf-dental.com
- —
- —
- [email protected]
- Phone
- +49742498880
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 320001431
Catalogue (2180)
Page 44 of 44| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Helmut Zepf | 17.008.04TI | FDA UDI | Class I | Active |
| Helmut Zepf | 46.007.05 | FDA UDI | Class I | Active |
| Helmut Zepf | 24.058.04 | FDA UDI | Class I | Active |
| Helmut Zepf | 15.222.00D | FDA UDI | Class I | Active |
| Helmut Zepf | 12.034.08Z | FDA UDI | Class I | Active |
| Helmut Zepf | KS26.514 | FDA UDI | Class I | Active |
| Helmut Zepf | 17.007.02TI | FDA UDI | Class I | Active |
| Helmut Zepf | 46.007.01 | FDA UDI | Class I | Active |
| Helmut Zepf | 46.013.05 | FDA UDI | Class I | Active |
| Helmut Zepf | 41.960.03WL | FDA UDI | Class I | Active |
| Helmut Zepf | 41.878.14 | FDA UDI | Class I | Active |
| Helmut Zepf | 14.705.00 | FDA UDI | Class I | Active |
| Helmut Zepf | 15.236.07D | FDA UDI | Class I | Active |
| Helmut Zepf | 17.335.16 | FDA UDI | Class I | Active |
| Helmut Zepf | 26.120.25TI | FDA UDI | Class I | Active |
| Helmut Zepf | 24.553.01 | FDA UDI | Class I | Active |
| Helmut Zepf | 47.990.50 | FDA UDI | Class I | Active |
| Helmut Zepf | 41.256.18 | FDA UDI | Class I | Active |
| Helmut Zepf | 23.074.14 | FDA UDI | Class I | Active |
| Helmut Zepf | 24.751.112GM5OX | FDA UDI | Class I | Active |
| Helmut Zepf | 12.035.01Z | FDA UDI | Class I | Active |
| Helmut Zepf | 46.431.14SC | FDA UDI | Class I | Active |
| Helmut Zepf | 12.035.08Z | FDA UDI | Class I | Active |
| Helmut Zepf | 46.051.11 | FDA UDI | Class I | Active |
| Helmut Zepf | 33.730.20 | FDA UDI | Class I | Active |
| Helmut Zepf | 12.218.00Z | FDA UDI | Class I | Active |
| Helmut Zepf | 22.821.17D | FDA UDI | Class I | Active |
| Helmut Zepf | 85.182.00 | FDA UDI | Class I | Active |
| Helmut Zepf | 38.428.22 | FDA UDI | Class I | Active |
| Helmut Zepf | 26.428.02 | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Helmut Zepf Medizintechnik Gmbh SEITINGEN Baden-Wurttemberg · DE FEI 3002807169