510(k) · Cleared
ClearedInvisalign 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 Nov 18, 2015 as substantially equivalent to K081960 (Align Technology, 2008) after a 331-day review. Its family tree reaches back 3 generations to 1978. 41 later devices descend from it.
- Decided
- Nov 18, 2015
- Review
- 331 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K780619 (1978). 41 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 2 generations backK981095 Align SystemAlign Technology · 1998
- 1 generation backK081960 Invisalign SystemAlign Technology · 2008
- This deviceK143630 Invisalign SystemAlign Technology, Inc. · 2015
- Descendant · cites it directly · 18 of its ownK181739 Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018
- Descendant · 2 generations on · 13 of its ownK220287 Invisalign SystemAlign Technology, Inc. · 2022 · Recalled
- Descendant · cites it directly · 10 of its ownK203737 Spark Clear Aligner SystemOrmco Corporation · 2021
- Descendant · 2 generations on · 7 of its ownK212660 Smylio Invisible Clear AlignersSmylio, Inc. · 2021
- Descendant · cites it directly · 6 of its ownK182826 Ormco Spark Aligner SystemSybron Dental Specialties · 2018
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K181739Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018 · cites it directly18descendants
- K220287Invisalign SystemAlign Technology, Inc. · 2022 · 2 generations on13descendants
- K203737Spark Clear Aligner SystemOrmco Corporation · 2021 · cites it directly10descendants
- K212660Smylio Invisible Clear AlignersSmylio, Inc. · 2021 · 2 generations on7descendants
- K182826Ormco Spark Aligner SystemSybron Dental Specialties · 2018 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −2 | K981095 | Align System | Align Technology | 1998 | — |
| −1 | K081960 | Invisalign System | Align Technology | 2008 | — |
| 0 (this device) | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| +1 | K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | 2018 | — |
| +2 | K220287 | Invisalign System | Align Technology, Inc. | 2022 | 1 |
| +1 | K203737 | Spark Clear Aligner System | Ormco Corporation | 2021 | — |
| +2 | K212660 | Smylio Invisible Clear Aligners | Smylio, Inc. | 2021 | — |
| +1 | K182826 | Ormco Spark Aligner System | Sybron Dental Specialties | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 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 |
|---|---|---|---|
| * | K081960 | Invisalign SystemSummary page 4…tment of malocclusion. Equivalent Device: The modified Invisalign System is substantially equivalent in intended use and/or method of operation to the Invisalign System (K081960). A comparison of the current and modified Invisalign System demonstrates that the device is substantially equivalent in terms of… | 2008 |
What descends from it? (41)
See all 415 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 37 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K181739 (Align Technology, Inc., 2018) has gone furthest, with 18 descendants of its own.
- 8 other devices also cite its predicate K081960.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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/K143630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143630: 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/K143630
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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