ArchForm is ArchForm, Inc.’s orthodontic design software that turns a patient’s intraoral scan into a staged clear aligner setup and prepares the models for 3D printing in your office. The FDA cleared it through the 510(k) process on December 16, 2021 (K213916). ArchForm publishes no prices on its saved pages, so pricing is on request.
Quick verdict
ArchForm suits an orthodontic practice that wants to design its own aligner cases and print or thermoform them in-house, and the FDA record covers that core planning use. The vendor also sells factory-made aligners, direct-print aligners, design services and white-label tools for aligner brands and labs, so you can mix in-house and outsourced work.
Where it falls short is evidence, price and privacy. Two independent 2026 studies tested ArchForm’s automatic tooth segmentation, and in both another program came out ahead. No price is listed, and none of the saved pages mention HIPAA or a BAA. Ask for a quote, a BAA in writing and a demo on your own scans before you commit.
ArchForm at a glance
On paper, ArchForm has an FDA clearance and a scan-based workflow built for making aligners in your office. Pricing and the HIPAA row are the two to chase.
| Vendor | ArchForm, Inc. |
|---|---|
| What it does | Designs and stages clear aligner treatment from 3D scans and exports print-ready models |
| Who it’s for | Orthodontists making aligners in-house, plus aligner brands and labs, per the vendor |
| Pricing | Pricing on request (checked October 21, 2026) |
| FDA status | FDA 510(k) cleared, K213916 (December 16, 2021) |
| HIPAA / BAA | Not stated on the vendor’s site |
| Integrations | STL files from all intraoral scanners, per the vendor; an API and bulk export scripts for aligner brands and labs; no PMS integration listed |
| Data checked | October 21, 2026 |
What is ArchForm?
ArchForm is planning software for clear aligner cases that the doctor designs. You upload a scan as an .stl file, the software trims, segments and auto-aligns the teeth, and you move teeth to their final position while it generates the stages in between, the vendor says. The FDA summary describes it as orthodontic appliance design and treatment simulation software that loads 3D scans of a patient’s dentition and can be used to fabricate dental casts using standard STL files for 3D printers.
The software sits inside a wider aligner business. ArchForm’s home page lists three ways to make the aligners: thermoforming over 3D-printed models in your office, printing aligners directly in its MemoryForm shape memory material, or ordering factory-made aligners from its robotic factory in California. It also sells indirect bonding for brackets. A dashboard handles orders for design services and aligners and tracks production. A separate enterprise page sells a custom-brandable browser editor, an API and manufacturing exports to aligner brands and labs.
The vendor makes several claims about time and cost. It says you can plan a treatment in 10 minutes and deliver an aligner or IDB tray in as little as 30 minutes with in-office printing. It also says ArchForm can reduce your aligner bill by over 50%, and the in-office page claims savings of 84% in lab bills. The home page says customers have saved $300M+ and that 7M+ aligners have been made, with a footnote saying the savings compare ArchForm’s average price per case with a leading alternative aligner company it doesn’t name. The enterprise page says the platform has been used on 800,000+ patient cases. These are the vendor’s figures; the saved pages don’t show how they were calculated.
Key features
ArchForm’s software and in-office pages list these tools, mostly for setting up and staging a case and preparing it for printing.
- Automatic setup: automatic segmentation that finds each tooth’s gingival border, with a brush tool for manual fixes, plus auto tooth labeling and auto-orientation of the midline and occlusal planes.
- Staging control: multiple intermediate goals, overcorrection, automatically planned sequential distalization, and an aligner count that changes with the tooth movements.
- Attachments: adjustable size, position and gingival tilt, multiple attachments per tooth and lingual attachments, plus automatic attachment placement.
- IPR: change the IPR amount with one click and the teeth move to match.
- Arch shape: align teeth to an arch shape you adjust with control points.
- Bite tools: bite stops added automatically to the first four anterior teeth or to single teeth, and bite shifts to set the end-of-treatment mandible position.
- Extractions and pontics: extract a tooth at any stage and place a pontic that changes size as the space closes.
- Hooks and cutouts: placement and sizing for hooks and elastics, with aligner cutouts added from the software.
- Lasso trimming: draw around excess material, such as palate, to cut it from the model.
- Print preparation: automatic supports for vertical printing, a label imprinted on the aligner, and hollow models with an internal honeycomb support. The vendor says the hollow export saves 50% of resin costs.
- Device sync: use ArchForm on several computers with patient data kept in sync, for example starting at the office and finishing on a laptop at home.
- Enterprise exports: bulk export from the command line, laser marking data and trimline exports for CNC milling or laser cutting, for labs and aligner brands.
ArchForm vs. what a treatment planning tool should have
On the vendor’s pages and the FDA record, ArchForm fully meets two of the five must-haves. FDA coverage and clinician sign-off are Partial, and there is no BAA or HIPAA statement.
Must have
| Feature | Status | Note |
|---|---|---|
| FDA clearance that covers the planning use the vendor advertises | Partial | K213916 covers model management, analysis, treatment simulation and design of casts for aligners or retainers. The 2021 summary doesn’t mention AI segmentation, direct-print aligners or indirect bonding trays. |
| Imports the practice’s scan data | Listed | STL from all intraoral scanners, per the vendor; the FDA summary lists intraoral scans and STL files. No CBCT import is listed. |
| The clinician reviews, edits and approves every plan | Partial | The doctor designs and edits the plan in the software; the pages don’t describe an approval step for outsourced design services |
| Exports files a lab or printer can use | Listed | STL casts per the FDA summary; print-ready models and trimline exports per the vendor |
| Data protection: BAA offered, security page | Not listed | No HIPAA or BAA statement on the saved pages |
Should have
| Feature | Status | Note |
|---|---|---|
| A published study that names the product | Study | Two independent 2026 studies of tooth segmentation accuracy |
| Progress tracking against the plan | FDA listing | The indications include inspecting and analyzing progress during treatment; the vendor’s pages don’t describe a progress-scan tool |
| Patient-facing view of the plan | Not listed | |
| Bite and occlusion analysis | FDA listing | The FDA summary lists overbite/overjet and an occlusal map; the vendor lists bite stops and bite shifts |
| Public pricing | Not listed | Pricing on request |
Nice to have
| Feature | Status | Note |
|---|---|---|
| Integration with the practice’s PMS | Not listed | The enterprise API connects to a brand’s portal or database, not a practice PMS |
| Outsourced planning service | Listed | Design services ordered through the dashboard |
| Browser access without installing software | Partial | A browser editor is sold to aligner brands; the main software is a download |
| Multiple users with roles and permissions | Not listed | Sync across devices is listed; roles and permissions are not |
The software proposes movements and stages, and the treating doctor decides the plan.
What the research says
Two 2026 studies in PubMed test ArchForm’s automatic tooth segmentation against other programs, and in both ArchForm was less accurate than at least one competitor. Both come from university and private-practice groups in Italy. None of the listed author affiliations is ArchForm. Neither study measured treatment results.
Four platforms, 270 models (European Journal of Orthodontics, 2026). Researchers at the University of Catania and a private practice in Catania compared the AI tooth segmentation of Medit LINK, DentOne, BlueSkyPlan and ArchForm on 270 digital dental models, selected retrospectively and split into nine groups, such as crowding, spacing, agenesis, brackets and attachments. They scored labeling success and segmentation quality and compared mesio-distal tooth widths with unsegmented models. BlueSkyPlan “consistently outperformed the other tested software” in labeling, surface segmentation and width accuracy across all model groups (P < 0.05). All four programs overestimated tooth widths. The authors conclude that automatic segmentation “still requires clinician supervision”. The abstract gives no separate figures for ArchForm.
Three programs on typodonts (Orthodontics & Craniofacial Research, 2026). A group from the Postgraduate School of Orthodontics at the University of Ferrara and private practices in Ferrara and Artena, Rome, scanned three typodonts with mild, moderate and severe crowding, segmented them in ArchForm, OrthoSystem and VISION, and superimposed each segmented tooth on a reference scan of the same tooth (the 28 removable teeth used to build the typodonts). The abstract says “OrthoSystem and VISION demonstrated better accuracy compared to ArchForm”, and that the programs differed “likely not to a clinically significant degree for most of the discrepancies found.” Crowding did not appear to affect accuracy. Segmented teeth tended to be oversized, and the authors warn that overestimated mesiodistal widths can compromise the accuracy of IPR during clear aligner therapy.
The PubMed search for “ArchForm” in titles and abstracts on October 21, 2026 returned 44 records. Of the 25 records saved from that search, the other 23 don’t evaluate the software; most of them use “archform” as the anatomy term for the shape of the dental arch. The FDA summary for K213916 reports software verification and validation testing only, and no clinical study.
FDA status and privacy
ArchForm is FDA 510(k) cleared. The FDA’s 510(k) database lists K213916, the ArchForm Orthodontic Software System from Archform, Inc., cleared on December 16, 2021 as substantially equivalent to the Orchestrate 3D Orthodontic Software. It is a Class II, prescription-use device reviewed by the Dental panel, product code PNN.
The indications for use, shortened: 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. It works from 3D models of the patient’s dentition before treatment, can be applied during treatment to inspect and analyze progress, and can be used at the end to evaluate whether the outcome matches the planned objectives. Users need training and domain knowledge in orthodontics and dedicated training in the software.
The summary lists Windows 10 and macOS Catalina as minimum operating systems and the maxilla and mandible as supported areas. It describes the software as submitted in 2021 and doesn’t mention the AI segmentation, direct-print aligners or indirect bonding trays the vendor’s pages now advertise. We found no PMA entry under ArchForm’s name.
On privacy, none of the saved pages (home, software, in-office and enterprise) mention HIPAA, a BAA or security certifications. The home, in-office and enterprise pages link to a privacy policy that we did not save. The software page says patient data stays in sync across your computers. Ask ArchForm for a signed BAA and its security documentation before you upload patient scans.
Pricing
ArchForm pricing is on request (checked October 21, 2026). To get a quote, book a demo or an onboarding meeting from ArchForm’s home page.
Who it’s for
ArchForm is built for orthodontists who want to design aligner cases themselves and make aligners in their own office, the vendor’s pages say, and for aligner brands and labs that need planning and manufacturing software. The FDA clearance requires users trained in orthodontics and in the software.
It fits if you already have, or plan to buy, a 3D printer and thermoforming setup, or if you want to start with braces and finish with aligners, which the vendor promotes. If you need a signed BAA up front, a published price, PMS integration or a patient-facing plan viewer, the saved pages don’t list them. Read the two studies above first if segmentation accuracy is your main concern; ArchForm trailed other programs in both.
FAQ
Is ArchForm FDA cleared?
Yes. The FDA’s 510(k) database lists the ArchForm Orthodontic Software System from Archform, Inc. as cleared on December 16, 2021, under K213916. The clearance covers orthodontic model analysis, treatment simulation and virtual appliance design, including dental casts for aligner trays or retainers, for prescription use.
How much does ArchForm cost?
Pricing on request. ArchForm’s saved pages, checked October 21, 2026, list no price for the software, design services or aligners. Contact the vendor for a quote.
Does ArchForm work with my intraoral scanner?
ArchForm says it integrates with all intraoral scanners and that you upload scans as .stl files. The FDA summary lists intraoral scans and STL files as inputs. The saved pages don’t name specific scanner brands.
How accurate is ArchForm’s tooth segmentation?
Two independent 2026 studies found it less accurate than at least one competing program. A study of 270 digital models found BlueSkyPlan ahead of ArchForm and two others, and a typodont study found OrthoSystem and VISION more accurate than ArchForm, though its authors say the programs differed “likely not to a clinically significant degree for most of the discrepancies found.” The 270-model study concludes that automatic segmentation still requires clinician supervision.
Does ArchForm replace the orthodontist?
No. The FDA indications say users need training and domain knowledge in orthodontics and dedicated training in the software. The doctor designs and edits the plan in ArchForm.
Does ArchForm sign a BAA?
The saved pages don’t say. The home, software, in-office and enterprise pages don’t mention HIPAA or a BAA, so ask ArchForm directly before you upload patient data.
How this review was put together
We didn’t use ArchForm. This review is built from ArchForm’s home, software, in-office and enterprise pages, the FDA’s 510(k) and PMA databases and the K213916 decision document, and a PubMed search for “ArchForm” in titles and abstracts. Only the two studies from that search that test the software itself are included here. The other records use “archform” for the shape of the dental arch or don’t evaluate the software. Some blocks on the in-office page read like leftover template text that doesn’t describe ArchForm, so we didn’t use them. We did not collect user reviews for this tool, so there are no user ratings or user comments here. Everything was checked on October 21, 2026.
Sources
- ArchForm: home page, accessed October 21, 2026
- ArchForm: design software page, accessed October 21, 2026
- ArchForm: in-office aligners page, accessed October 21, 2026
- ArchForm: enterprise page, accessed October 21, 2026
- FDA 510(k) database: K213916, ArchForm Orthodontic Software System, accessed October 21, 2026
- FDA: K213916 decision letter and 510(k) summary, accessed October 21, 2026
- openFDA device 510(k) and PMA databases (search for “ArchForm”), accessed October 21, 2026
- PubMed search: “ArchForm”[tiab], accessed October 21, 2026
- Assessment of the accuracy of automated tooth segmentation using different orthodontic platforms and models with a large-scale clinical applicability. European Journal of Orthodontics, 2026, accessed October 21, 2026
- Accuracy of Automatic Tooth Segmentation via Three Different CAD/CAM Orthodontic Software Packages: A Comparative Assessment. Orthodontics & Craniofacial Research, 2026, accessed October 21, 2026
