510(k) · Cleared
ClearedLingOral Dental Design System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou ChohoTech Co., Ltd. · PNN Orthodontic Software
Cleared on May 8, 2026 as substantially equivalent to K233625 (Ray Co., Ltd., 2024) after an 88-day review. Its family tree reaches back 5 generations to 2009.
- Decided
- May 8, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K082207 (2009). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK082207 Orthocad IQCadent, Inc. · 2009
- 4 generations backK152086 3Shape Ortho System3Shape A/S · 2016
- 3 generations backK171295 ULab Systems Treatment Planning SoftwareUlab Systems, Inc. · 2018
- 2 generations backK180941 Ortho System3Shape A/S · 2018
- 1 generation backK233625 Raydent SWRay Co., Ltd. · 2024
- This deviceK260419 LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K082207 | Orthocad IQ | Cadent, Inc. | 2009 | — |
| −4 | K152086 | 3Shape Ortho System | 3Shape A/S | 2016 | — |
| −3 | K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | 2018 | — |
| −2 | K180941 | Ortho System | 3Shape A/S | 2018 | — |
| −1 | K233625 | Raydent SW | Ray Co., Ltd. | 2024 | — |
| 0 (this device) | K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K233625 | Raydent SWSummary page 5…ic Bracket (Software) Class 2 Product Code PNN 5. Predicate device Device Name:RAYDENT SW, 510(k) Number: K233625 RAY Co., Ltd. 6. Device Description LingOral is a software that provides tools to simulate treatment plans based on patient… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K233625.
How does its category compare?
All PNN devicesPNN Orthodontic Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
LingOral is a software designed to assist dental professionals in planning patient treatment and designing treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include prosthetic devices (Veneer, Crown, Bridge, In/Onlay) and orthodontic devices (Clear Aligner).
To use LingOral, users must have the necessary education and domain knowledge in orthodontic or prosthodontic practice and receive dedicated training in the use of the software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260419: LingOral Dental Design System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260419
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026