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 Jan 17, 2018 as substantially equivalent to K152086 (3Shape A/S, 2016) after a 229-day review. Its family tree reaches back 2 generations to 2009. 14 later devices descend from it.
- Decided
- Jan 17, 2018
- Review
- 229 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082207 (2009). 14 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK082207 Orthocad IQCadent, Inc. · 2009
- 1 generation backK152086 3Shape Ortho System3Shape A/S · 2016
- This deviceK171634 Ortho System3Shape A/S · 2018
- Descendant · cites it directly · 3 of its ownK191720 BRUIS Software SuiteMechanodontics, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK181112 Orchestrate 3DOrchestrate 3D · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK223518 iOrthoShanghai EA Medical Instruments Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK212828 BRIUS Planner SoftwareBrius Technologies, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK232653 Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio…Blue Sky Bio, LLC · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K191720BRUIS Software SuiteMechanodontics, Inc. · 2020 · cites it directly3descendants
- K181112Orchestrate 3DOrchestrate 3D · 2018 · cites it directly3descendants
- K223518iOrthoShanghai EA Medical Instruments Co., Ltd. · 2023 · cites it directly2descendants
- K212828BRIUS Planner SoftwareBrius Technologies, Inc. · 2021 · 2 generations on2descendants
- K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082207 | Orthocad IQ | Cadent, Inc. | 2009 | — |
| −1 | K152086 | 3Shape Ortho System | 3Shape A/S | 2016 | — |
| 0 (this device) | K171634 | Ortho System | 3Shape A/S | 2018 | — |
| +1 | K191720 | BRUIS Software Suite | Mechanodontics, Inc. | 2020 | — |
| +1 | K181112 | Orchestrate 3D | Orchestrate 3D | 2018 | 1 |
| +1 | K223518 | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | 2023 | — |
| +2 | K212828 | BRIUS Planner Software | Brius Technologies, Inc. | 2021 | — |
| +2 | K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Blue Sky Bio, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K152086 | 3Shape Ortho SystemSummary page 4…l retainers has the same intended use, scientific concept, performance specification and technical characteristics as the primary predicate device 3Shape Ortho SystemTM (K152086) from 3Shape A/S. Based on the information and supporting documentation provided, the Ortho System™ and the primary predicate de… | 2016 |
| † | K161884 | Ortho System | 2017 |
| † | K163677 | Ortho System | 2017 |
What descends from it? (14)
See all 146 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 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K191720 (Mechanodontics, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K152086.
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?
The 3Shape Ortho System™ 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 (Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media) 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…
Read the full statement (132 words)
The 3Shape Ortho System™ 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 (Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media) 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 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/K171634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171634: 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/K171634
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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