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Nuvola

GRUPPO EUROPEO DI ORTODONZIA SRL · Model NA · UDI-DI 08057760170018

NXC Prescription

510(k) clearances

18,595

Adverse events (1 deaths)

Recalls

Facilities

Description

The Nuvola® device is a doctor-prescribed series of removable plastic orthodontic aligners intended as an alternative to conventional wire and bracket technology. The Nuvola® gently moves teeth in small increments from their original state to a final, treated state for improved dental alignment. The system is used in patients with primary, mixed, and permanent dentition. The system consists of a series of doctor prescribed and customized plastic aligners (thermoformed PET-G sheeting material) that gently move the patient’s teeth in small increments from their original state to a more optimal, treated state to address malocclusion. The first device of the treatment matches the patient’s dentition in its current state and then each subsequent aligner stage has the shape of the dentition shifted gradually toward the final desired position.

Recalls

Date	Firm	Reason
2024-11-22	3M Company - Health Care Business	Attachments may not mate with the tooth as intended in the digital treatment design.
2024-11-04	Straight Smile, LLC	Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindicatio

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.