Cleared Traditional

Nuvola (K222418) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222418 · Gruppo Europeo Ortodonzia Srl · Dental device
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Oct 2022
Decision
58d
Days
Class 2
Risk

K222418 is an FDA 510(k) clearance for the Nuvola. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Gruppo Europeo Ortodonzia Srl (Rome, IT). The FDA issued a Cleared decision on October 7, 2022 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gruppo Europeo Ortodonzia Srl devices

Submission Details

510(k) Number K222418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2022
Decision Date October 07, 2022
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Donawa Lifescience Consulting Srl
Carlo d`Alessandro

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K222418.
DentCare Aligners
K222918 · Dentcare Dental Lab Pvt , Ltd. · Nov 2022
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K223355 · Graphy, Inc. · Nov 2022
CREOKORREKT Aligners
K211427 · Creodent Prosthetics, Ltd. · Oct 2022
ClearCorrect System
K220140 · Clearcorrect, LLC · Oct 2022
MyClearALIGN Dental Aligner System
K221475 · Key Dental Technologies, LLC · Aug 2022
Clear Aligner
K213026 · Shenzhen Meiming Dentistry Technology Co., Ltd. · Aug 2022