FDA clears RealGUIDE dental implant software

The U.S. FDA has cleared RealGUIDE, a 510(k) software device from 3DIEMME SRL intended for computer-aided design and manufacturing of dental surgical guides.

• The device is classified under product code QIH, which is designated for dental implant surgical planning software.
• The clearance was processed through the FDA's Radiology committee, indicating the software's primary interaction with radiological imaging data such as cone-beam computed tomography (CBCT).
• No independent performance data was disclosed in the regulatory summary, which is standard for a 510(k) clearance based on a predicate device.

Automated summary

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