Nuvola

Aligner, Sequential

Gruppo Europeo Ortodonzia Srl

The following data is part of a premarket notification filed by Gruppo Europeo Ortodonzia Srl with the FDA for Nuvola.

Pre-market Notification Details

• Device ID: K222418
• 510k Number: K222418
• Device Name: Nuvola
• Classification: Aligner, Sequential
• Applicant: Gruppo Europeo Ortodonzia Srl via Cropani, 118 A/B Rome, IT 00173
• Contact: Massimiliano Bucceri
• Correspondent: Carlo D`Alessandro; Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, IT 00153
• Product Code: NXC
• CFR Regulation Number: 872.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-08-10
• Decision Date: 2022-10-07