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. · PNN Orthodontic Software
Cleared on Sep 25, 2026 as substantially equivalent to K252380 (Align Technology, Inc., 2025) after an 88-day review. Its family tree reaches back 9 generations to 1978.
- Decided
- Sep 25, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K780619 (1978). No later device cites it as a predicate yet.
- Root · 9 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 5 generations between
- 3 generations backK232233 Invisalign System with Mandibular Advancement Featuring Occlusal…Align Technology, Inc. · 2023
- 2 generations backK241412 Invisalign SystemAlign Technology, Inc. · 2024
- 1 generation backK252380 Invisalign SystemAlign Technology, Inc. · 2025
- This deviceK262196 Invisalign SystemAlign Technology, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 8 generations backK981095 Align SystemAlign Technology · 1998
- 7 generations backK081960 Invisalign SystemAlign Technology · 2008
- 6 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 5 generations backK181739 Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018
- 4 generations backK220287 Invisalign SystemAlign Technology, Inc. · 2022 · Recalled
- 3 generations backK232233 Invisalign System with Mandibular Advancement Featuring Occlusal…Align Technology, Inc. · 2023
- 2 generations backK241412 Invisalign SystemAlign Technology, Inc. · 2024
- 1 generation backK252380 Invisalign SystemAlign Technology, Inc. · 2025
- This deviceK262196 Invisalign SystemAlign Technology, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −8 | K981095 | Align System | Align Technology | 1998 | — |
| −7 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −6 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −5 | K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | 2018 | — |
| −4 | K220287 | Invisalign System | Align Technology, Inc. | 2022 | 1 |
| −3 | K232233 | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | Align Technology, Inc. | 2023 | — |
| −2 | K241412 | Invisalign System | Align Technology, Inc. | 2024 | — |
| −1 | K252380 | Invisalign System | Align Technology, Inc. | 2025 | — |
| 0 (this device) | K262196 | Invisalign System | Align Technology, Inc. | 2026 | — |
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 PNN? 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 PNN device
- #1 K233625 Raydent SWscore 14.2 · 4 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 |
|---|---|---|---|
| * | K252380 | Invisalign SystemSummary page 6…Product Codes NXC, PNN Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate Device K252380 Predicate Trade Name Invisalign System (Primary Predicate is listed first) Product Codes NXC, PNN… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 48 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All PNN devicesPNN Orthodontic Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PNN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNN
177in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PNN
1in 2024
MAUDE reports naming product code PNN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 5 | 229 | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 7 | 221 | 0 | 0 |
| 2021 | 4 | 58 | 1 | 0 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 3 | 90 | 0 | 0 |
| 2024 | 4 | 177 | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
The Invisalign System is intended for the orthodontic treatment of malocclusion in patients with primary,
mixed (primary and permanent), or permanent dentition. The optional mandibular advancement feature(s)
are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262196: 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/K262196
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026