510(k) · Cleared
ClearedOrtho System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3Shape A/S · PNN Orthodontic Software
Cleared on Oct 17, 2018 as substantially equivalent to K171295 (Ulab Systems, Inc., 2018) after a 203-day review. Its family tree reaches back 3 generations to 2009. 8 later devices descend from it.
- Decided
- Oct 17, 2018
- Review
- 203 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K082207 (2009). 8 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK082207 Orthocad IQCadent, Inc. · 2009
- 2 generations backK152086 3Shape Ortho System3Shape A/S · 2016
- 1 generation backK171295 ULab Systems Treatment Planning SoftwareUlab Systems, Inc. · 2018
- This deviceK180941 Ortho System3Shape A/S · 2018
- Descendant · cites it directly · 2 of its ownK233625 Raydent SWRay Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK232564 Align StudioLaon Medi, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK192244 Arcad SmileStudio and Aligner SystemArcadlab · 2020
- Descendant · 2 generations on · 0 of its ownK260419 LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK253343 Celebrace SoftwareCelebrace · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K233625Raydent SWRay Co., Ltd. · 2024 · cites it directly2descendants
- K232564Align StudioLaon Medi, Inc. · 2024 · cites it directly1descendant
- K192244Arcad SmileStudio and Aligner SystemArcadlab · 2020 · cites it directly1descendant
- K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd. · 2026 · 2 generations on0descendants
- K253343Celebrace SoftwareCelebrace · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K082207 | Orthocad IQ | Cadent, Inc. | 2009 | — |
| −2 | K152086 | 3Shape Ortho System | 3Shape A/S | 2016 | — |
| −1 | K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | 2018 | — |
| 0 (this device) | K180941 | Ortho System | 3Shape A/S | 2018 | — |
| +1 | K233625 | Raydent SW | Ray Co., Ltd. | 2024 | — |
| +1 | K232564 | Align Studio | Laon Medi, Inc. | 2024 | — |
| +1 | K192244 | Arcad SmileStudio and Aligner System | Arcadlab | 2020 | — |
| +2 | K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. | 2026 | — |
| +2 | K253343 | Celebrace Software | Celebrace | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K171295 | ULab Systems Treatment Planning SoftwareSummary page 4…rovided, and has the same intended use, scientific concept, performance specification and technical characteristics as the primary predicate device ULab Systems UDesign (K171295) from ULab Systems, Inc. Both software devices are used by Dental Professionals in orthodontic treatment planning (before, durin… | 2018 |
| † | K163677 | Ortho System | 2017 |
| † | K171634 | Ortho System | 2018 |
| † | K062828 | Mouthguard and Aligner Materials | 2006 |
What descends from it? (8)
5 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 9 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233625 (Ray Co., Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K171295.
How does its category compare?
All PNN devicesPNN Orthodontic Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Ortho System™ for dental retainers and dental cast for sequential aligners 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 3D models of the patient’s dentition before the start of an orthodontic treatment.
The use of the Ortho System™ 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/K180941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180941: Ortho System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180941
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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