Is this your brand? Sign in to claim ownership.
Sign in to claim this brandE. Hahnenkratt GmbH
US
Last updated May 23, 2026
What E. Hahnenkratt GmbH makes
E. Hahnenkratt GmbH manufactures reusable dental instruments, including dental mirrors, surgical probes, and matrix bands for dental restorations. Their portfolio also includes preformed root canal posts, laryngeal mirrors, matrix band tensioners, and specialized dental drill bits for pin/post applications. These tools are designed for use in endodontic and restorative dental procedures.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States, adhering to applicable domestic regulatory requirements for reusable dental instruments.
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 E. Hahnenkratt GmbH manufacture?
E. Hahnenkratt GmbH specializes in reusable dental instruments. Their product range includes dental mirrors for oral examinations, root canal posts for endodontic treatments, dental surgical probes for precision procedures, and reusable dental matrix bands used in restorative work. They also produce laryngeal mirrors for medical examinations, matrix band tensioners to assist in dental restorations, and specialized pin/post dental drill bits for preparing tooth structures. These devices are designed for use in endodontics and restorative dentistry.
Where is E. Hahnenkratt GmbH based, and what regulatory framework applies to their devices?
E. Hahnenkratt GmbH is based in the United States. Their devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Specifically, these reusable dental instruments are classified as Class I medical devices, which typically pose the lowest risk among FDA-regulated products. This classification means they are subject to general controls, including registration and listing requirements, but may not require pre-market approval or other stringent reviews.
Are E. Hahnenkratt GmbH’s devices listed in any regulatory registries?
Yes, E. Hahnenkratt GmbH’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use. Listing in this registry ensures transparency and traceability, which is particularly important for reusable instruments like those produced by the company, as they may be sterilized and reused across multiple procedures.
How are E. Hahnenkratt GmbH’s devices classified under FDA regulations?
E. Hahnenkratt GmbH’s devices are classified as Class I medical devices under FDA regulations. This classification is based on their intended use and risk profile—reusable dental instruments like mirrors, probes, and matrix bands are generally considered low-risk due to their routine, non-invasive applications in dental procedures. Class I devices are subject to FDA’s general controls, which include registration, listing, and adherence to good manufacturing practices, but they do not require pre-market approval or post-market surveillance beyond standard compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 316001098
Catalogue (636)
Page 13 of 13| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hahnenkratt | 44603 | FDA UDI | Class I | Active |
| Hahnenkratt | 720X7 | FDA UDI | Class I | Active |
| E. Hahnenkratt GmbH | H757RX24 | FDA UDI | Class I | Active |
| Hahnenkratt | 4300D16 | FDA UDI | Class I | Active |
| Hahnenkratt | 730X8 | FDA UDI | Class I | Active |
| E. Hahnenkratt GmbH | B5232 | FDA UDI | Class I | Active |
| Hahnenkratt | 626C | FDA UDI | Class I | Active |
| Hahnenkratt | 42615 | FDA UDI | Class I | Active |
| E. Hahnenkratt GmbH | B6165 | FDA UDI | Class I | Active |
| Hahnenkratt | 440 | FDA UDI | Class I | Active |
| Hahnenkratt | 6530X5 | FDA UDI | Class I | Active |
| E. Hahnenkratt GmbH | 5184 | FDA UDI | Class I | Active |
| Hahnenkratt | 6695 | FDA UDI | Class I | Active |
| Hahnenkratt | 45513C3 | FDA UDI | Class I | Active |
| Hahnenkratt | 45512 | FDA UDI | Class I | Active |
| Hahnenkratt | 43603C3 | FDA UDI | Class I | Active |
| E. Hahnenkratt GmbH | B6220 | FDA UDI | Class I | Active |
| Hahnenkratt | 4400D11 | FDA UDI | Class I | Active |
| Hahnenkratt | 594 | FDA UDI | Class I | Active |
| Hahnenkratt | 10356 | FDA UDI | Class I | Active |
| Hahnenkratt | 544D | FDA UDI | Class I | Active |
| Hahnenkratt | 4460D11C5 | FDA UDI | Class I | Active |
| Hahnenkratt | 41X102 | FDA UDI | Class I | Active |
| Hahnenkratt | H756RX22 | FDA UDI | Class I | Active |
| Hahnenkratt | H950RX12 | FDA UDI | Class I | Active |
| Hahnenkratt | 5013 | FDA UDI | Class I | Active |
| Hahnenkratt | 6070 | FDA UDI | Class I | Active |
| E. Hahnenkratt GmbH | 7113 | FDA UDI | Class I | Active |
| Hahnenkratt | H750RX30 | FDA UDI | Class I | Active |
| Hahnenkratt | B443 | FDA UDI | Class I | Active |
| E. Hahnenkratt GmbH | 536X3 | FDA UDI | Class I | Active |
| Hahnenkratt | 6561 | FDA UDI | Class I | Active |
| Hahnenkratt | 42613 | FDA UDI | Class I | Active |
| E. Hahnenkratt GmbH | 7317 | FDA UDI | Class I | Active |
| E. Hahnenkratt GmbH | 7104 | FDA UDI | Class I | Active |
| E. Hahnenkratt GmbH | B6101 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- E. Hahnenkratt Gmbh KOENIGSBACH-STEIN Baden-Wurttemberg · DE FEI 4395