510(k) · Cleared
Recalled · Class II · 2021Orchestrate 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orchestrate 3D · PNN Orthodontic Software
Cleared on Nov 26, 2018 as substantially equivalent to K171634 (3Shape A/S, 2018) after a 213-day review. Its family tree reaches back 3 generations to 2009. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 26, 2018
- Review
- 213 days
- Class
- Class II
- Product code
- PNN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K082207 (2009). 3 later devices descend from it, 2 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 deviceK181112 Orchestrate 3DOrchestrate 3D · 2018
- Descendant · cites it directly · 1 of its ownK213916 ArchForm Orthodontic Software SystemArchform, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK253565 SureSmile SoftwareDentsply Sirona, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK241153 Progressive Orthodontics AppProgressive Aligners, Inc. · 2024
Most influential descendants
Showing 3 of 3 · 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) | K181112 | Orchestrate 3D | Orchestrate 3D | 2018 | — |
| +1 | K213916 | ArchForm Orthodontic Software System | Archform, Inc. | 2021 | — |
| +2 | K253565 | SureSmile Software | Dentsply Sirona, Inc. | 2026 | — |
| +1 | K241153 | Progressive Orthodontics App | Progressive Aligners, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K171634 | Ortho SystemSummary page 4…Processing, Radiological Device Classification: Class II, 21 CFR 872.5470 Primary Predicate 3Shape Ortho System (K171634) Devices: Device Description: The Orchestrate 3D Orthodontic Software is an orthodontic appliance design and treatment simu… | 2018 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2021 | Class II | Z-0334-2022 | Process control | Due to product label/labeling being altered from it's approved state. |
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, K213916 (Archform, Inc., 2021) 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. 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 Orchestrate 3D Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are based on 3D models of the patient’s dentition before the start of an orthodontic treatment. It can also be applied during…
Read the full statement (137 words)
The Orchestrate 3D Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 Orchestrate 3D 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/K181112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181112: Orchestrate 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181112
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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