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510(k) Data Aggregation
K Number
K222418Device Name
Nuvola
Manufacturer
Gruppo Europeo Ortodonzia srl
Date Cleared
2022-10-07
(58 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Gruppo Europeo Ortodonzia srl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nuvola® aligner is intended for the orthodontic treatment of malocclusion.
Device Description
The Nuvola® device is a doctor-prescribed series of removable plastic 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 rements 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 of the dentition shifted gradually toward the final desired position.
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