510(k) · Cleared
ClearediOrtho
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai EA Medical Instruments Co., Ltd. · PNN Orthodontic Software
Cleared on Jun 13, 2023 as substantially equivalent to K171634 (3Shape A/S, 2018) after a 202-day review. Its family tree reaches back 3 generations to 2009. 2 later devices descend from it.
- Decided
- Jun 13, 2023
- Review
- 202 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K082207 (2009). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK082207 Orthocad IQCadent, Inc. · 2009
- 2 generations backK152086 3Shape Ortho System3Shape A/S · 2016
- 1 generation backK171634 Ortho System3Shape A/S · 2018
- This deviceK223518 iOrthoShanghai EA Medical Instruments Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK232653 Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio…Blue Sky Bio, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK242892 Cristaline Aligners Z FLXCristaline Aligners GmbH · 2024
Most influential descendants
Showing 2 of 2 · See allView 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 | K171634 | Ortho System | 3Shape A/S | 2018 | — |
| 0 (this device) | K223518 | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | 2023 | — |
| +1 | K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Blue Sky Bio, LLC | 2024 | — |
| +2 | K242892 | Cristaline Aligners Z FLX | Cristaline Aligners GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K171634 | Ortho SystemSummary page 4…) Product Code: PNN Device Classification: Class II, 21 CFR 872.5470 Predicate Device: 3Shape A/S Ortho System (K171634) Reference Device: Wuxi EA Medical Instruments Technologies Limited Clear Aligner… | 2018 |
| † | K203688 | Clear Aligner | 2021 |
| † | K171122 | CEREC Ortho Software | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | 2024 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232653 (Blue Sky Bio, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K171634.
How does its category compare?
All PNN devicesPNN Orthodontic Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
iOrtho is intended for use as a medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of…
Read the full statement (126 words)
iOrtho is intended for use as a medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of iOrtho 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/K223518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223518: iOrtho.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223518
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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