510(k) · Cleared
ClearedArchForm Orthodontic Software System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Archform, Inc. · PNN Orthodontic Software
Cleared on Dec 16, 2021 as substantially equivalent to K181112 (Orchestrate 3D, 2018) after a 1-day review. Its family tree reaches back 4 generations to 2009. 1 later device descends from it.
- Decided
- Dec 16, 2021
- Review
- 1 day
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K082207 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK082207 Orthocad IQCadent, Inc. · 2009
- 3 generations backK152086 3Shape Ortho System3Shape A/S · 2016
- 2 generations backK171634 Ortho System3Shape A/S · 2018
- 1 generation backK181112 Orchestrate 3DOrchestrate 3D · 2018 · Recalled
- This deviceK213916 ArchForm Orthodontic Software SystemArchform, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK253565 SureSmile SoftwareDentsply Sirona, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253565SureSmile SoftwareDentsply Sirona, Inc. · 2026 · cites it directly0descendants
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 | K171634 | Ortho System | 3Shape A/S | 2018 | — |
| −1 | K181112 | Orchestrate 3D | Orchestrate 3D | 2018 | 1 |
| 0 (this device) | K213916 | ArchForm Orthodontic Software System | Archform, Inc. | 2021 | — |
| +1 | K253565 | SureSmile Software | Dentsply Sirona, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K181112 | Orchestrate 3DSummary page 4…Number: 21 CFR 872.5470 Product Code: PNN Review Panel: Dental Predicate Device: Orchestrate 3D Orthodontic Software – K181112 Device Description: The ArchForm Orthodontic Software System is an orthodontic appliance de… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253565 | SureSmile Software | 2026 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K253565 (Dentsply Sirona, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181112.
How does its category compare?
All PNN devicesPNN Orthodontic Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 ArchForm Orthodontic Software System is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied…
Read the full statement (139 words)
The ArchForm Orthodontic Software System is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 the ArchForm Orthodontic Software System 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 as stated in the FDA summary.
https://510kreport.com/device/K213916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213916: ArchForm Orthodontic Software System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213916
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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