Nuvola

Basic Information

• Brand Name: Nuvola
• Primary DI: 08057760170018
• Version / Model: NA
• Company Name: GRUPPO EUROPEO DI ORTODONZIA SRL
• Labeler DUNS: 434398279
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-31
• Public Version: 1
• Public Version Date: 2026-04-08
• Public Version Status: New
• Public Device Record Key: 25596806-fbb0-4c02-95f4-de9a9175996e

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXC	Aligner, Sequential	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44738	Orthodontic progressive aligner	A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08057760170018	GS1

Premarket Submissions

Submission Number	Supplement Number
K222418	000