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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 12 of 13
DeviceModel / ReferenceRegistriesClassStatus
Hahnenkratt 6170
FDA UDI
Class IActive
Hahnenkratt 720X2
FDA UDI
Class IActive
E. Hahnenkratt GmbH 40X150
FDA UDI
Class IActive
Hahnenkratt H757RX26
FDA UDI
Class IActive
Hahnenkratt 6685
FDA UDI
Class IActive
Hahnenkratt 44602C5
FDA UDI
Class IActive
Hahnenkratt 41X103
FDA UDI
Class IActive
Hahnenkratt 6730X3KFO
FDA UDI
Class IActive
Hahnenkratt 10135
FDA UDI
Class IActive
Hahnenkratt 44X103
FDA UDI
Class IActive
Hahnenkratt 427
FDA UDI
Class IActive
Hahnenkratt 476
FDA UDI
Class IActive
E. Hahnenkratt GmbH 6640
FDA UDI
Class IActive
E. Hahnenkratt GmbH 6671
FDA UDI
Class IActive
E. Hahnenkratt GmbH B6690
FDA UDI
Class IActive
Hahnenkratt 10347
FDA UDI
Class IActive
Hahnenkratt 21
FDA UDI
Class IActive
E. Hahnenkratt GmbH 7116
FDA UDI
Class IActive
Hahnenkratt 474
FDA UDI
Class IActive
Hahnenkratt 736X4
FDA UDI
Class IActive
Hahnenkratt 10034
FDA UDI
Class IActive
E. Hahnenkratt GmbH B6696
FDA UDI
Class IActive
Hahnenkratt 6232
FDA UDI
Class IActive
Hahnenkratt 719X10
FDA UDI
Class IActive
Hahnenkratt 702X5
FDA UDI
Class IActive
Hahnenkratt 43701
FDA UDI
Class IActive
Hahnenkratt 60X15
FDA UDI
Class IActive
Hahnenkratt 41X13
FDA UDI
Class IActive
Hahnenkratt 42311
FDA UDI
Class IActive
E. Hahnenkratt GmbH 40X14
FDA UDI
Class IActive
E. Hahnenkratt GmbH 40X4
FDA UDI
Class IActive
Hahnenkratt 443
FDA UDI
Class IActive
Hahnenkratt 5232
FDA UDI
Class IActive
Hahnenkratt 540D
FDA UDI
Class IActive
Hahnenkratt 44701C3
FDA UDI
Class IActive
E. Hahnenkratt GmbH 6181
FDA UDI
Class IActive
Hahnenkratt 545A
FDA UDI
Class IActive
E. Hahnenkratt GmbH 7306
FDA UDI
Class IActive
Hahnenkratt 43601C5
FDA UDI
Class IActive
Hahnenkratt 620F
FDA UDI
Class IActive
Hahnenkratt H951RX10
FDA UDI
Class IActive
Hahnenkratt 43703C3
FDA UDI
Class IActive
Hahnenkratt 721X5
FDA UDI
Class IActive
Hahnenkratt H756RX28
FDA UDI
Class IActive
Hahnenkratt 621G
FDA UDI
Class IActive
Hahnenkratt 477
FDA UDI
Class IActive
Hahnenkratt 43001
FDA UDI
Class IActive
Hahnenkratt 563
FDA UDI
Class IActive
E. Hahnenkratt GmbH 7313
FDA UDI
Class IActive
E. Hahnenkratt GmbH 7107
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