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E. 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
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
316001098

Catalogue (636)

Page 6 of 13
DeviceModel / ReferenceRegistriesClassStatus
E. Hahnenkratt GmbH 7103
FDA UDI
Class IActive
E. Hahnenkratt GmbH 623
FDA UDI
Class IActive
Hahnenkratt 461
FDA UDI
Class IActive
Hahnenkratt 636X4
FDA UDI
Class IActive
E. Hahnenkratt GmbH B5200
FDA UDI
Class IActive
Hahnenkratt 431
FDA UDI
Class IActive
Hahnenkratt 4460D11C3
FDA UDI
Class IActive
Hahnenkratt 42611C3
FDA UDI
Class IActive
Hahnenkratt H757RX28
FDA UDI
Class IActive
Hahnenkratt 540G
FDA UDI
Class IActive
Hahnenkratt 622D
FDA UDI
Class IActive
E. Hahnenkratt GmbH B6061
FDA UDI
Class IActive
E. Hahnenkratt GmbH 7312
FDA UDI
Class IActive
Hahnenkratt 10054
FDA UDI
Class IActive
Hahnenkratt 620D
FDA UDI
Class IActive
E. Hahnenkratt GmbH 620
FDA UDI
Class IActive
Hahnenkratt B6161
FDA UDI
Class IActive
Hahnenkratt 667FG
FDA UDI
Class IActive
Hahnenkratt 580
FDA UDI
Class IActive
Hahnenkratt 6500X1
FDA UDI
Class IActive
Hahnenkratt 721X3
FDA UDI
Class IActive
Hahnenkratt B600G
FDA UDI
Class IActive
Hahnenkratt H757RX16
FDA UDI
Class IActive
Hahnenkratt 625C
FDA UDI
Class IActive
Hahnenkratt 711X3
FDA UDI
Class IActive
Hahnenkratt 43604C5
FDA UDI
Class IActive
Hahnenkratt 42005
FDA UDI
Class IActive
Hahnenkratt 42x113
FDA UDI
Class IActive
Hahnenkratt 44702
FDA UDI
Class IActive
Hahnenkratt 731X3
FDA UDI
Class IActive
Hahnenkratt 560
FDA UDI
Class IActive
E. Hahnenkratt GmbH B6686
FDA UDI
Class IActive
Hahnenkratt H756RX30
FDA UDI
Class IActive
Hahnenkratt 44703
FDA UDI
Class IActive
Hahnenkratt 43704
FDA UDI
Class IActive
Hahnenkratt 592
FDA UDI
Class IActive
E. Hahnenkratt GmbH B6071
FDA UDI
Class IActive
Hahnenkratt 43601C3
FDA UDI
Class IActive
Hahnenkratt 770X4
FDA UDI
Class IActive
Hahnenkratt 25
FDA UDI
Class IActive
E. Hahnenkratt GmbH 40X13
FDA UDI
Class IActive
Hahnenkratt 10046
FDA UDI
Class IActive
Hahnenkratt 6700X3KFO
FDA UDI
Class IActive
Hahnenkratt 545D
FDA UDI
Class IActive
Hahnenkratt 4370D16C3
FDA UDI
Class IActive
Hahnenkratt H956RX06
FDA UDI
Class IActive
Hahnenkratt 624A
FDA UDI
Class IActive
Hahnenkratt H751RX28
FDA UDI
Class IActive
Hahnenkratt 44604
FDA UDI
Class IActive
Hahnenkratt 44003
FDA UDI
Class IActive

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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