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Scheu-Dental

US

Last updated May 23, 2026

What Scheu-Dental makes

Scheu-Dental manufactures dental appliance fabrication materials made from thermoplastic, orthodontic wires, orthodontic palate expander screws (both self-removable and bonded types), and orthodontic power arms. Specific products include CHROMIUM Wire, MENZANIUM® Wire, DURAN®, DURAN®+, DURASOFT® pd, VECTOR® Screw, SCHEU-Anchor, J-Clasp oblique, and BIOPLAST® Color neon red.

All devices manufactured by Scheu-Dental are classified as Class I medical devices and are listed in the FDA's Unique Device Identification (FDA UDI) system. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does Scheu-Dental manufacture?

Scheu-Dental manufactures dental appliance fabrication materials made from thermoplastic, orthodontic wires, orthodontic palate expander screws (both self-removable and bonded types), and orthodontic power arms. This is based on the device categories and example devices provided in the data, which include products like CHROMIUM Wire, DURAN®, and VECTOR® Screw.

Where is Scheu-Dental based?

Scheu-Dental is based in the United States, as explicitly stated in the COMPANY and COUNTRY fields of the device data, which identify the company's location as US.

In which regulatory registry are Scheu-Dental's devices listed?

Scheu-Dental's devices are listed in the FDA's Unique Device Identification (FDA UDI) system, as indicated by the LISTED IN field in the device data, which specifies fda_udi as the registry where its devices are registered.

How are Scheu-Dental's devices classified?

All devices manufactured by Scheu-Dental are classified as Class I medical devices, as stated in the DEVICE CLASSES field of the device data, which confirms that every device falls under this risk-based classification.

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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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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Catalogue (310)

Page 7 of 7
DeviceModel / ReferenceRegistriesClassStatus
BIOCRYL® C clear 3147.2
FDA UDI
Class IActive
BIOPLAST® XTREME clear 3298.1
FDA UDI
Class IActive
BIOPLAST® XTREME black 3297.1
FDA UDI
Class IActive
BIOPLAST® Color white 3445.1
FDA UDI
Class IActive
DURASOFT® pd 3388.2
FDA UDI
Class IActive
VECTOR® Screw 2496.1
FDA UDI
Class IActive
Adams Clasp 2104.1
FDA UDI
Class IActive
Bioplast® 3188.2
FDA UDI
Class IActive
Herbst 5479.1
FDA UDI
Class IActive
De-Bond 200 K883418
FDA 510(k)
Class IActive

Related Companies

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Scheu-Dental Gmbh ISERLOHN North Rhine-Westphalia · DE FEI 3005547450