510(k) · Cleared
ClearedInvisalign System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Align Technology · NXC Aligner, Sequential
Cleared on Dec 17, 2008 as substantially equivalent to K981095 (Align Technology, 1998) after a 161-day review. Its family tree reaches back 2 generations to 1978. 82 later devices descend from it.
- Decided
- Dec 17, 2008
- Review
- 161 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K780619 (1978). 82 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 1 generation backK981095 Align SystemAlign Technology · 1998
- This deviceK081960 Invisalign SystemAlign Technology · 2008
- Descendant · cites it directly · 41 of its ownK143630 Invisalign SystemAlign Technology, Inc. · 2015
- Descendant · 2 generations on · 18 of its ownK181739 Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018
- Descendant · cites it directly · 15 of its ownK180241 Orthocaps TwinalignerOrtho Caps GmbH · 2018
- Descendant · 3 generations on · 13 of its ownK220287 Invisalign SystemAlign Technology, Inc. · 2022 · Recalled
- Descendant · cites it directly · 13 of its ownK163689 3M Clear Tray Aligner3M Unitek Corporation · 2017
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K143630Invisalign SystemAlign Technology, Inc. · 2015 · cites it directly41descendants
- K181739Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018 · 2 generations on18descendants
- K180241Orthocaps TwinalignerOrtho Caps GmbH · 2018 · cites it directly15descendants
- K220287Invisalign SystemAlign Technology, Inc. · 2022 · 3 generations on13descendants
- K1636893M Clear Tray Aligner3M Unitek Corporation · 2017 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −1 | K981095 | Align System | Align Technology | 1998 | — |
| 0 (this device) | K081960 | Invisalign System | Align Technology | 2008 | — |
| +1 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| +2 | K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | 2018 | — |
| +1 | K180241 | Orthocaps Twinaligner | Ortho Caps GmbH | 2018 | — |
| +3 | K220287 | Invisalign System | Align Technology, Inc. | 2022 | 1 |
| +1 | K163689 | 3M Clear Tray Aligner | 3M Unitek Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 8 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 13 | 0 |
| 2025 | 10 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K981095 | Align SystemSummary page 3…formation: This Premarket Notification is being submitted solely to incorporate the above listed labeling changes to the existing Invisalign system (K981095). , There are no changes in the technological characteristics of the modified device when compare… | 1998 |
What descends from it? (82)
See all 829 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 30 years and passes through 2 companies; a new generation was cleared every 20.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143630 (Align Technology, Inc., 2015) has gone furthest, with 41 descendants of its own.
- 8 other devices also cite its predicate K981095.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081960: 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/K081960
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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