Structur CAD

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Temporary dental crown/bridge

Model / Ref / Catalog

6072, 6071, 6078, 6076, 6077, block, disc

Primary DI / UDI-DI

E22160721, E22160711, E22160781, E22160761, E22160771

Basic UDI-DI

B-E22160761, B-E22160721, B-E22160711, B-E22160771, B-E22160781

510(k) Number

K201090 ↗

FDA Product Code

EBG

EMDN Code

Q01020605 Temporary dental prostheses

GMDN Term

Temporary dental crown/bridge

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 872.3770

EU market of registration

Germany

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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See all devices from VOCO GmbH →

• What types of dental restorations can be created using the Structur CAD system, and how does it ensure precision in fabrication?

  The Structur CAD system is designed to create custom dental restorations such as crowns, bridges, and inlays. It achieves precision by integrating with milling machines to fabricate patient-specific restorations directly from dental CAD files, ensuring a high level of accuracy and fit for prosthetic dentistry. The system relies on digital design to guide the milling process, minimizing human error and maximizing consistency in the final product.

• Is the Structur CAD system intended for use in dental laboratories or clinics, and what equipment does it require?

  Structur CAD is supplied exclusively as a software solution and is intended for use in dental laboratories and clinics. To function, it requires compatible milling equipment to physically fabricate the restorations based on the digital designs created within the software. The system itself does not include milling hardware but works in tandem with existing compatible machines.

• How is the Structur CAD system regulated, and what compliance standards does it adhere to?

  Structur CAD holds FDA 510(k) clearance under the classification code K201090, with a decision of Substantially Equivalent (SESE) for dental applications. It is also compliant with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). These regulatory pathways ensure the system meets stringent safety, performance, and quality standards for dental software in the United States and European markets.

• Is the Structur CAD system single-use or reusable, and what are the recommended storage conditions for the software?

  Structur CAD is designed for single-use applications in controlled environments, such as dental laboratories or clinics, where the software is utilized to create patient-specific restorations. While the software itself is not a physical consumable, it must be operated in a sterile or hygienic environment to maintain the integrity of the digital workflow. Storage conditions are not specified for the software itself, but it should be kept on a secure, dedicated computer system to prevent data corruption or unauthorized access.