510(k) · Cleared
Recalled · Class II · 2022Invisalign System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Align Technology, Inc. · NXC Aligner, Sequential
Cleared on Apr 7, 2022 as substantially equivalent to K181739 (Align Technology, Inc., 2018) after a 65-day review. Its family tree reaches back 5 generations to 1978. 13 later devices descend from it. It has been recalled once.
- Decided
- Apr 7, 2022
- Review
- 65 days
- Class
- Class II
- Product code
- NXC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K780619 (1978). 13 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 4 generations backK981095 Align SystemAlign Technology · 1998
- 3 generations backK081960 Invisalign SystemAlign Technology · 2008
- 2 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 1 generation backK181739 Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018
- This deviceK220287 Invisalign SystemAlign Technology, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK232233 Invisalign System with Mandibular Advancement Featuring Occlusal…Align Technology, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK241412 Invisalign SystemAlign Technology, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK222418 NuvolaGruppo Europeo Ortodonzia Srl · 2022
- Descendant · 3 generations on · 1 of its ownK252380 Invisalign SystemAlign Technology, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK232074 Serafin®Tns Co., Ltd. · 2024
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksAlign Technology, Inc. · 2023 · cites it directly3descendants
- K241412Invisalign SystemAlign Technology, Inc. · 2024 · 2 generations on2descendants
- K222418NuvolaGruppo Europeo Ortodonzia Srl · 2022 · cites it directly2descendants
- K252380Invisalign SystemAlign Technology, Inc. · 2025 · 3 generations on1descendant
- K232074Serafin®Tns Co., Ltd. · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −4 | K981095 | Align System | Align Technology | 1998 | — |
| −3 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −2 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −1 | K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | 2018 | — |
| 0 (this device) | K220287 | Invisalign System | Align Technology, Inc. | 2022 | — |
| +1 | K232233 | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | Align Technology, Inc. | 2023 | — |
| +2 | K241412 | Invisalign System | Align Technology, Inc. | 2024 | — |
| +1 | K222418 | Nuvola | Gruppo Europeo Ortodonzia Srl | 2022 | — |
| +3 | K252380 | Invisalign System | Align Technology, Inc. | 2025 | — |
| +1 | K232074 | Serafin® | Tns Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 K252380 Invisalign Systemscore 15.0 · 8 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 |
|---|---|---|---|
| * | K181739 | Invisalign System with Mandibular Advancement FeatureSummary page 5…of this Special 510(k), referred to as the Invisalign System, is a modification to the predicate device the Invisalign System with Mandibular Advancement Feature (MAF) (K181739, cleared on Oct 26, 2018) and is inclusive of both standard aligners and aligners with mandibular advancement feature. The propri… | 2018 |
What descends from it? (13)
See all 136 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2022 | Class II | Z-1017-2023 | Software design | 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 44 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K232233 (Align Technology, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K181739.
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?
The Invisalign System is intended for the orthodontic treatment of malocclusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220287: Invisalign System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220287
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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