510(k) · Cleared
Cleared3Shape Ortho 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 Apr 28, 2016 as substantially equivalent to K082207 (Cadent, Inc., 2009) after a 276-day review. Its family tree reaches back 1 generation to 2009. 33 later devices descend from it.
- Decided
- Apr 28, 2016
- Review
- 276 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082207 (2009). 33 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK082207 Orthocad IQCadent, Inc. · 2009
- This deviceK152086 3Shape Ortho System3Shape A/S · 2016
- Descendant · cites it directly · 14 of its ownK171634 Ortho System3Shape A/S · 2018
- Descendant · cites it directly · 13 of its ownK171295 ULab Systems Treatment Planning SoftwareUlab Systems, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK180941 Ortho System3Shape A/S · 2018
- Descendant · cites it directly · 5 of its ownK171122 CEREC Ortho SoftwareDentsply Sirona · 2018
- Descendant · 2 generations on · 3 of its ownK191720 BRUIS Software SuiteMechanodontics, Inc. · 2020
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K171634Ortho System3Shape A/S · 2018 · cites it directly14descendants
- K171295ULab Systems Treatment Planning SoftwareUlab Systems, Inc. · 2018 · cites it directly13descendants
- K180941Ortho System3Shape A/S · 2018 · 2 generations on8descendants
- K171122CEREC Ortho SoftwareDentsply Sirona · 2018 · cites it directly5descendants
- K191720BRUIS Software SuiteMechanodontics, Inc. · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082207 | Orthocad IQ | Cadent, Inc. | 2009 | — |
| 0 (this device) | K152086 | 3Shape Ortho System | 3Shape A/S | 2016 | — |
| +1 | K171634 | Ortho System | 3Shape A/S | 2018 | — |
| +1 | K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | 2018 | — |
| +2 | K180941 | Ortho System | 3Shape A/S | 2018 | — |
| +1 | K171122 | CEREC Ortho Software | Dentsply Sirona | 2018 | — |
| +2 | K191720 | BRUIS Software Suite | Mechanodontics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K082207 | Orthocad IQSummary page 4…rthodontic Software); LLZ Predicate Device The 3Shape Ortho System™ Software has the same intended uses and technical characteristics as primary predicate OrthoCAD iQ (K082207) from Cadent Inc. and reference predicate Dolphin Imaging from Patterson Dental Supply (K110430) as listed in “Volume 005, Compar… | 2009 |
| † | K110430 | Dolphin Imaging | 2011 |
What descends from it? (33)
See all 338 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171634 | Ortho System | 2018 | 14 |
| K171295 | ULab Systems Treatment Planning Software | 2018 | 13 |
| K171122 | CEREC Ortho Software | 2018 | 5 |
| K232429 | Titan Dental Design | 2023 | 1 |
| K232549 | NemoCast | 2023 | 0 |
| K212173 | HDH Treatment Planning System | 2022 | 0 |
| K192701 | DIBS (Digital Indirect Bonding System) | 2020 | 0 |
| K163677 | Ortho System | 2017 | 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?
How does its category compare?
All PNN devicesPNN Orthodontic Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
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…
Read the full statement (131 words)
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152086: 3Shape 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/K152086
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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