510(k) · Cleared
ClearedClevaligner Software (V1.0.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clevaligner, Ltd. · PNN Orthodontic Software
Cleared on Jan 11, 2024 as substantially equivalent to K212770 (Softsmile, Inc., 2021) after a 59-day review. Its family tree reaches back 4 generations to 2009.
- Decided
- Jan 11, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K082207 (2009). No later device cites it as a predicate yet.
- 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 backK212770 VisionSoftsmile, Inc. · 2021
- This deviceK233616 Clevaligner Software (V1.0.0)Clevaligner, Ltd. · 2024
View 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 | K212770 | Vision | Softsmile, Inc. | 2021 | — |
| 0 (this device) | K233616 | Clevaligner Software (V1.0.0) | Clevaligner, Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K212770 | VisionSummary page 6…e 1 of 7 PREDICATE DEVICE For the planned and proposed 510(k), the Clevaligner Software will have a primary predicate device as SoftSmile, Inc. Vision (K212770). DEVICE DESCRIPTION Clevaligner Software imports patient 3-D digital scans and provides the orthodontic treatment planning o… | 2021 |
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 15 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K212770.
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?
The Clevaligner software is intended for use as a medical device standalone software, providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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…
Read the full statement (134 words)
The Clevaligner software is intended for use as a medical device standalone software, providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 Clevaligner Software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well 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/K233616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233616: Clevaligner Software (V1.0.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233616
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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