510(k) · Cleared
ClearedRaydent SW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ray Co., Ltd. · PNN Orthodontic Software
Cleared on May 16, 2024 as substantially equivalent to K180941 (3Shape A/S, 2018) and 1 other predicate after a 185-day review. Its family tree reaches back 4 generations to 2009. 2 later devices descend from it.
- Decided
- May 16, 2024
- Review
- 185 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K082207 (2009). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK082207 Orthocad IQCadent, Inc. · 2009
- 3 generations backK152086 3Shape Ortho System3Shape A/S · 2016
- 2 generations backK171295 ULab Systems Treatment Planning SoftwareUlab Systems, Inc. · 2018
- 1 generation backK180941 Ortho System3Shape A/S · 2018
- This deviceK233625 Raydent SWRay Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK260419 LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253343 Celebrace SoftwareCelebrace · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K082207 | Orthocad IQ | Cadent, Inc. | 2009 | — |
| −3 | K152086 | 3Shape Ortho System | 3Shape A/S | 2016 | — |
| −2 | K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | 2018 | — |
| −1 | K180941 | Ortho System | 3Shape A/S | 2018 | — |
| 0 (this device) | K233625 | Raydent SW | Ray Co., Ltd. | 2024 | — |
| +1 | K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. | 2026 | — |
| +1 | K253343 | Celebrace Software | Celebrace | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K180941 | Ortho SystemSummary page 6…CEREC Ortho Software ChairsideCAD Manufacturer 3Shape A/S Dentsply Sirona EXOCAD GMBH K180941 K171122 Exemption from 510(K) Number Traditional 510k T… | 2018 |
| * | K171122 | CEREC Ortho SoftwareSummary page 6…ChairsideCAD Manufacturer 3Shape A/S Dentsply Sirona EXOCAD GMBH K180941 K171122 Exemption from 510(K) Number Traditional 510k Traditional 510k Prema… | 2018 |
What descends from it? (2)
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 15 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K260419 (Hangzhou ChohoTech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K180941.
How does its category compare?
All PNN devicesPNN Orthodontic Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
RAYDENT SW 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 RAYDENT SW, 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/K233625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233625: Raydent SW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233625
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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