510(k) · Cleared
ClearedSureSmile Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona, Inc. · PNN Orthodontic Software
Cleared on Mar 4, 2026 as substantially equivalent to K213916 (Archform, Inc., 2021) after a 107-day review. Its family tree reaches back 5 generations to 2009.
- Decided
- Mar 4, 2026
- Review
- 107 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K082207 (2009). 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 backK171634 Ortho System3Shape A/S · 2018
- 2 generations backK181112 Orchestrate 3DOrchestrate 3D · 2018 · Recalled
- 1 generation backK213916 ArchForm Orthodontic Software SystemArchform, Inc. · 2021
- This deviceK253565 SureSmile SoftwareDentsply Sirona, Inc. · 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 | K171634 | Ortho System | 3Shape A/S | 2018 | — |
| −2 | K181112 | Orchestrate 3D | Orchestrate 3D | 2018 | 1 |
| −1 | K213916 | ArchForm Orthodontic Software System | Archform, Inc. | 2021 | — |
| 0 (this device) | K253565 | SureSmile Software | Dentsply Sirona, Inc. | 2026 | — |
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.
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 3.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
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?
The SureSmile Software is indicated for use as a front-end device for management of orthodontic models, systematic inspection, detailed analysis, treatment planning and simulation and the design of custom appliance systems, which may include sequential aligners, retainers, IDB trays, brackets, or wires, and dental casts. These applications are based on 3D models of the patient's dentition before the start of the orthodontic treatment. It can also be…
Read the full statement (139 words)
The SureSmile Software is indicated for use as a front-end device for management of orthodontic models, systematic inspection, detailed analysis, treatment planning and simulation and the design of custom appliance systems, which may include sequential aligners, retainers, IDB trays, brackets, or wires, and dental casts. These applications are based on 3D models of the patient's dentition before the start of the 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 SureSmile Software 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/K253565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253565: SureSmile Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253565
Report an extraction error
Are you the manufacturer?
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