510(k) · Cleared
ClearedAlign Studio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laon Medi, Inc. · PNN Orthodontic Software
Cleared on Mar 12, 2024 as substantially equivalent to K180941 (3Shape A/S, 2018) and 1 other predicate after a 201-day review. Its family tree reaches back 4 generations to 2009. 1 later device descends from it.
- Decided
- Mar 12, 2024
- Review
- 201 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K082207 (2009). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK082207 Orthocad IQCadent, Inc. · 2009
- 3 generations backK152086 3Shape Ortho System3Shape A/S · 2016
- 2 generations backK171295 ULab Systems Treatment Planning SoftwareUlab Systems, Inc. · 2018
- 1 generation backK180941 Ortho System3Shape A/S · 2018
- This deviceK232564 Align StudioLaon Medi, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK250198 Laon OrthoLaon Medi, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250198Laon OrthoLaon Medi, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K082207 | Orthocad IQ | Cadent, Inc. | 2009 | — |
| −3 | K152086 | 3Shape Ortho System | 3Shape A/S | 2016 | — |
| −2 | K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | 2018 | — |
| −1 | K180941 | Ortho System | 3Shape A/S | 2018 | — |
| 0 (this device) | K232564 | Align Studio | Laon Medi, Inc. | 2024 | — |
| +1 | K250198 | Laon Ortho | Laon Medi, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 K262196 Invisalign Systemscore 14.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K180941 | Ortho SystemSummary page 6…[21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate device #1 510(k) Number: K180941 Applicant: 3Shape A/S Classification Name: Orthodontic Software Trade N… | 2018 |
| * | K171122 | CEREC Ortho SoftwareSummary page 6… Classification Name: Orthodontic Software Trade Name: Ortho System Predicate device #2 510(k) Number: K171122 Applicant: Dentsply Sirona Classification Name: Orthodontic Software Tr… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250198 | Laon Ortho | 2025 | 0 |
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 15 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K250198 (Laon Medi, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K180941.
How does its category compare?
All PNN devicesPNN Orthodontic Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Align Studio is intended for use as a medical front-end device providing tools for management of orthodontic models,
systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3Dmodels of
the patient’s dentition before the start of an orthodontic treatment.
The use of the Align Studio requires the user to have the necessary training and domain knowledge in the practice of
orthodontics, as well as to have received a dedicated training in the use of the software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232564: Align Studio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232564
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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