510(k) · Cleared
ClearedNuvola
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gruppo Europeo Ortodonzia Srl · NXC Aligner, Sequential
Cleared on Oct 7, 2022 as substantially equivalent to K220287 (Align Technology, Inc., 2022) after a 58-day review. Its family tree reaches back 6 generations to 1978. 2 later devices descend from it.
- Decided
- Oct 7, 2022
- Review
- 58 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K780619 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 5 generations backK981095 Align SystemAlign Technology · 1998
- 4 generations backK081960 Invisalign SystemAlign Technology · 2008
- 3 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 2 generations backK181739 Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018
- 1 generation backK220287 Invisalign SystemAlign Technology, Inc. · 2022 · Recalled
- This deviceK222418 NuvolaGruppo Europeo Ortodonzia Srl · 2022
- Descendant · cites it directly · 0 of its ownK260722 SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK242929 Fas Aligner SystemXplora 3D Europe S.L · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −5 | K981095 | Align System | Align Technology | 1998 | — |
| −4 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −3 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −2 | K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | 2018 | — |
| −1 | K220287 | Invisalign System | Align Technology, Inc. | 2022 | 1 |
| 0 (this device) | K222418 | Nuvola | Gruppo Europeo Ortodonzia Srl | 2022 | — |
| +1 | K260722 | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | 2026 | — |
| +1 | K242929 | Fas Aligner System | Xplora 3D Europe S.L | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NXC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NXC device
- #1 K220287 Invisalign Systemscore 20.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220287 | Invisalign SystemSummary page 4…nvisalign System Name/Address of Sponsor Align Technology, Inc. , 2820 Orchard Parkway, San Jose, CA 95134 Trade/Proprietary Name Invisalign System (K220287) Common Name Aligner, Sequential Classification Name Orthodontic Plastic Bracket === Page 5… | 2022 |
| † | K212496 | Ortho Aligner System | 2021 |
| † | K152086 | 3Shape Ortho System | 2016 |
| † | K200125 | Thermoforming Sheet Materials | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 44 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K260722 (Dentsply Sirona, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K220287.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NXC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NXC
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NXC
4,523in 2025
MAUDE reports naming product code NXC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 59 |
| 2012 | 2 | — | 0 | 24 |
| 2013 | 4 | 124 | 0 | 28 |
| 2014 | 0 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 43 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 3 | 85 | 0 | 47 |
| 2018 | 11 | 116 | 0 | 67 |
| 2019 | 16 | 182 | 0 | 127 |
| 2020 | 16 | 230 | 0 | 175 |
| 2021 | 20 | 97 | 0 | 929 |
| 2022 | 19 | 137 | 0 | 605 |
| 2023 | 13 | 152 | 0 | 433 |
| 2024 | 14 | 105 | 2 | 8,991 |
| 2025 | 11 | 61 | 0 | 4,523 |
| 2026 | 5 | 127 | 0 | — |
What is it indicated for?
Nuvola® aligner is intended for the orthodontic treatment of malocclusion
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222418: Nuvola.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222418
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026