Medical devices & diagnostics · Orthodontics

ArchForm

Treatment planning software that lets an orthodontist design a clear aligner case and print it in the office the same day, plus a robotic factory in California for practices that would rather outsource. One FDA clearance stands behind the company, and it covers the software.

The orthodontist as manufacturer

Dr. Rooney runs an orthodontic practice in Mahopac, New York. For years he did what almost every orthodontist does: took a scan, filled in a prescription form, shipped the case to a large aligner maker, and waited weeks for a box of plastic trays.

Then he started making them himself. First refinements, then everything. He printed the models on a desktop 3D printer in his own office, thermoformed the aligners over them, and trimmed them to his own preference.

The software he used to move the teeth was ArchForm. “what I like about ArchForm is I do not have to complete prescription forms and explain how I would like teeth moved, I just do it,” he told Formlabs, the printer maker, in 2022.

That is the product in one sentence. ArchForm does not sell aligners to patients. It tries to turn the orthodontist into the manufacturer.

Where the money goes

The 2025 orthodontic practice survey published by Orthodontic Products put the average US clear aligner fee at $6,301, against $6,219 for brackets and wires. The average orthodontist started 87 aligner cases that year.

A large share of that fee never reaches the practice. TechCrunch reported in March 2018 that orthodontists were paying about $1,700 per patient to Invisalign, and 3DPrint.com repeated the figure in 2020, noting that much of the doctor's margin was controlled by Align.

Doctors had a second grievance. Align's iTero scanner would only send scans to Invisalign. Two dental practices sued in 2020 and 2021 alleging a monopoly in aligners and in the scanners used to order them. Align called the claims meritless and won summary judgment in February 2024.

The founder

Andrew Martz grew up around the problem. “I was inspired to start the company because I worked in my father’s orthodontic office.” The hardware had arrived, he told TechCrunch, and the software had not: easy-to-use tools to move teeth virtually were “the missing piece to allow every orthodontist to 3D print their own aligners.”

He was 28 when the factory opened in 2020, per TCT Magazine and Manufactur3D. Y Combinator took the company into its Winter 2018 batch, the year SmileDirectClub was the loudest name in the category. SmileDirectClub went bankrupt in 2023. ArchForm's customers, the orthodontists, are still there, and Martz is still chief executive and the applicant contact on the FDA file.

Software, then a factory, then a clearance

In October 2020 ArchForm opened its own 3D printing factory and began selling finished aligners to doctors who did not want to run a lab. Orthodontic Products, TCT Magazine, Manufactur3D and 3DPrint.com all covered it that week. Shipping was quoted at 10 to 14 days.

Fourteen months later, on December 16, 2021, the FDA cleared the ArchForm Orthodontic Software System under 510(k) K213916. An accredited third party reviewed the submission, and the decision came one day after FDA received it.

The company has since moved up the stack again, into aligners printed directly rather than thermoformed over a model, sold with a resin, a curing chamber and a centrifuge. That is where the record and the marketing stop agreeing.

What is proven, and what is still claimed

Read plainly: ArchForm holds a real, checkable FDA clearance, and it is for a planning tool that designs printable models. Everything downstream of the model sits outside it. That is ordinary when a doctor thermoforms a tray over a printed cast from a material the material maker has cleared. It is a larger question once a company sells the resin, the printer settings, the curing chamber and the finished tray as one validated system, then tells buyers the hardware is part of an FDA approval it does not appear to hold.

What to watch

• Any new 510(k) in Archform, Inc.'s name covering a direct print aligner, a resin or the curing hardware.
• Whether the direct print page is corrected to say clearance rather than approval.
• A second Form D. The only one on file was made in April 2020.
• Published clinical data. The literature on in-house aligners is growing; none of it names this company.

In their words

ArchForm funding profile on HVCFHealthcare Venture Capital Fund

Related companies

• Perceptive Technologies: Also in Medical Devices. A handheld scanner that sees inside a tooth with infrared light instead of X-rays, and a robot arm that cuts the tooth
• Standard Cyborg: Also in Medical Devices. A Y Combinator startup that printed shower legs for amputees, became the software prosthetists used to design sockets, then became a computer vision SDK
• Morphle Labs: Also in Medical Devices. A Bengaluru and Boston company selling whole slide scanners and, now, a robotic microtome into cancer diagnostics
• Shift Labs: Also in Medical Devices. A handheld monitor that counts the drops falling through an IV drip chamber and alarms when the rate drifts

Sources

1. Public recordFDA 510(k) clearance letter and summary, K213916FDA · Dec 16, 2021
2. Public recordFDA 510(k) database entry, K213916FDA · Sep 21, 2026
3. Public recordFDA product classification, code PNNFDA · Sep 21, 2026
4. Public recordForm D, ArchForm Inc., CIK 0001807066SEC EDGAR · Apr 6, 2020
5. IndependentThis 3D-printing startup helps orthodontists straighten your teethTechCrunch, Megan Rose Dickey · Mar 19, 2018
6. IndependentArchForm's 3D printed aligner factory set to reduce orthodontist costs3DPrint.com, Vanesa Listek · Oct 13, 2020
7. IndependentArchForm launches aligner production powered by DLP 3D printingTCT Magazine · Oct 9, 2020
8. IndependentArchForm opens 3D printed aligner factory for doctorsManufactur3D, Abhimanyu Chavan · Oct 10, 2020
9. IndependentArchForm opens 3D printing aligner factoryOrthodontic Products, Alison Werner · Oct 12, 2020
10. IndependentFindings from the 2025 orthodontic practice surveyOrthodontic Products · 2026
11. IndependentLawsuit alleges anticompetitive practices by Align TechnologyOrthodontic Products, Steven Martinez · Jan 8, 2024
12. PartnerHow ArchForm and Formlabs brought aligner production in houseFormlabs Dental · Jun 14, 2022
13. CompanyAlign statement on summary judgment in two antitrust class actionsAlign Technology · Feb 22, 2024
14. CompanyArchForm home, pricing, in-office and direct print pagesarchform.com · Sep 2026