510(k) · Cleared
ClearedCEREC Ortho Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · PNN Orthodontic Software
Cleared on Jan 11, 2018 as substantially equivalent to K152086 (3Shape A/S, 2016) after a 269-day review. Its family tree reaches back 2 generations to 2009. 5 later devices descend from it.
- Decided
- Jan 11, 2018
- Review
- 269 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082207 (2009). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK082207 Orthocad IQCadent, Inc. · 2009
- 1 generation backK152086 3Shape Ortho System3Shape A/S · 2016
- This deviceK171122 CEREC Ortho SoftwareDentsply Sirona · 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 · 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
- Descendant · 2 generations on · 0 of its ownK250198 Laon OrthoLaon Medi, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K233625Raydent SWRay Co., Ltd. · 2024 · cites it directly2descendants
- K232564Align StudioLaon Medi, Inc. · 2024 · cites it directly1descendant
- K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd. · 2026 · 2 generations on0descendants
- K253343Celebrace SoftwareCelebrace · 2025 · 2 generations on0descendants
- K250198Laon OrthoLaon Medi, Inc. · 2025 · 2 generations on0descendants
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) | K171122 | CEREC Ortho Software | Dentsply Sirona | 2018 | — |
| +1 | K233625 | Raydent SW | Ray Co., Ltd. | 2024 | — |
| +1 | K232564 | Align Studio | Laon Medi, Inc. | 2024 | — |
| +2 | K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. | 2026 | — |
| +2 | K253343 | Celebrace Software | Celebrace | 2025 | — |
| +2 | K250198 | Laon Ortho | Laon Medi, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K152086 | 3Shape Ortho SystemSummary page 4…r the CEREC Ortho Software is: Predicate Device Name 510(k) Company Name 3Shape Ortho System™ K152086 3Shape A/S 4. Description of Device: The CEREC Ortho Software is stand-alone software which utilizes images of the pati… | 2016 |
What descends from it? (5)
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)
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 6.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233625 (Ray Co., Ltd., 2024) has gone furthest, with 2 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?
CEREC Ortho Software is intended for use with image data acquired from handheld intra oral 3D cameras and desktop laboratory scanners to create 3D virtual models to be used for data acquisition and modeling analysis for orthodontic patients and conditions. The CEREC Ortho Software 3D model data can be exported to orthodontic design software to aid in the design of orthodontic appliances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171122: CEREC Ortho Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171122
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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