SmileFy is an AI smile design and treatment planning platform that turns a patient photo and an intraoral scan into a smile simulation, a treatment plan and a 3D design ready to print or send to the lab, the vendor says. Plans start at $1,299 a year on SmileFy’s pricing page (checked October 20, 2026), and three published studies name the product.
Quick verdict
SmileFy is aimed at dentists who do cosmetic and restorative work and want to show patients a proposed smile at the consultation, then carry that design through to printed mock-ups and temporaries. Prices are public, and three 2026 studies name the product, none with vendor authors.
The gaps are on the regulatory and privacy side. We found no FDA listing under SmileFy’s name, and the two saved vendor pages say nothing about HIPAA, a BAA or security. The pages also name several features without describing them. Book the demo, ask for a BAA in writing, and ask which scanner files it accepts before you sign up.
SmileFy at a glance
SmileFy has public pricing and a clear workflow on paper. The FDA, HIPAA and integration rows are where the saved pages leave questions open.
| Vendor | SmileFy |
|---|---|
| What it does | AI smile simulation, treatment plan and 3D smile design from patient photos and intraoral scans, with print-ready models |
| Who it’s for | Dentists doing cosmetic and restorative cases; DSOs, dental labs and multi-clinic groups on the Enterprise plan, per the vendor |
| Pricing | Starter $1,299/year or $129/month; Professional $2,599/year or $259/month; Enterprise from $2,500/month; Design4Me design credits $100 each (checked October 20, 2026) |
| FDA status | No FDA listing found under the vendor’s name (searched October 20, 2026) |
| HIPAA / BAA | Not stated on the vendor’s site |
| Integrations | The vendor says it works with any intraoral scanner; STL exports; API access and system integration on Enterprise. No PMS named |
| Data checked | October 20, 2026 |
What is SmileFy?
SmileFy is software for planning cosmetic and restorative cases around a patient’s face and smile. The vendor describes the workflow in five steps: smile simulation, AI treatment plan, 3D design, 3D print and treatment. You upload the case, the AI analyzes the smile, and you get a treatment plan and a starting design, the home page says.
The selling point on the pricing page is that the simulation you show the patient becomes the design you print. SmileFy says the platform lets you “deliver exactly what was presented during the consultation” and collaborate with labs or colleagues. For practices that don’t want to do the design work, SmileFy sells Design4Me, a service in which its designer team creates the 3D design for you.
SmileFy’s home page makes three marketing claims: more than 200,000 smile simulations created, 60 seconds from photo to AI treatment plan, and 98% “reported case acceptance”. No source is given for these figures, so treat them as SmileFy’s own numbers.
Key features
SmileFy’s home and pricing pages name these features, most of them without saying how they work.
- Smile analysis and simulation: facial and smile harmony analysis and a smile simulation, with customization options, the vendor says.
- AI smile videos: included on both the Starter and Professional plans.
- AI treatment plan: a “structured clinical treatment plan” generated from the case.
- 3D smile design: a guided, facially driven 3D design workflow (Professional plan).
- Print-ready models and STL export: models for veneers, mock-ups, temporaries and All-on-X cases, with unlimited STL exports on the Professional plan.
- AI Articulator and All-on-X design workflow: listed as included in Professional; the pages don’t describe either one.
- Design4Me: outsourced 3D designs (smile trials, composite veneers, temporaries, implant bridges) with a 24-hour turnaround, delivered into your SmileFy account, where you can adjust them.
- Enterprise APIs: an AI Smile Simulation API, AI Design from STL API and 3D Print-Ready AI Design API, plus custom reporting and workflow configuration.
No installation is required, the pricing page says, and SmileFy works with any intraoral scanner. A footer link points to a SmileFy app download. Its FAQ lists questions on a free trial, hardware, scanner compatibility, plan changes and cancellation, but the saved copy doesn’t include the answers.
SmileFy vs. what a treatment planning tool should have
SmileFy meets two of the five must-haves on its saved pages: scan import and lab-ready exports. Clinician review is only partly described, and there is no FDA listing and no HIPAA or BAA statement.
Must have
| Feature | Status | Note |
|---|---|---|
| FDA clearance that covers the planning use the vendor advertises | Not listed | We found no listing in the FDA’s 510(k) and PMA databases on October 20, 2026 |
| Imports the practice’s scan data | Listed | Intraoral scans; the vendor says any scanner works. File formats aren’t named, except STL for the Enterprise API |
| The clinician reviews, edits and approves every plan | Partial | Customization options and in-app adjustment of Design4Me designs are listed; an approval step is not described |
| Exports files a lab or printer can use | Listed | Unlimited STL exports and print-ready models on the Professional plan |
| Data protection: BAA offered, security page | Not listed | No HIPAA, BAA or security statement on the saved pages |
Should have
| Feature | Status | Note |
|---|---|---|
| A published study that names the product | Study | Three 2026 studies in PubMed |
| Progress tracking against the plan | Not listed | |
| Patient-facing view of the plan | Listed | Smile simulations and AI smile videos |
| Bite and occlusion analysis | Partial | “AI Articulator” is named on the Professional plan but not described |
| Public pricing | Listed | Enterprise is “starting at” a monthly price |
Nice to have
| Feature | Status | Note |
|---|---|---|
| Integration with the practice’s PMS | Not listed | Enterprise lists API access and system integration without naming any system |
| Outsourced planning service | Listed | Design4Me |
| Browser access without installing software | Partial | “No installation required”, but the footer also links to an app download |
| Multiple users with roles and permissions | Not listed | Starter and Professional include 1 user |
A simulation or AI plan is a starting point for a conversation with the patient. What gets done is the treating dentist’s decision.
What the research says
Three 2026 studies in PubMed name SmileFy, all small and all from university groups in Egypt and Saudi Arabia. Two compared SmileFy designs with designs made in exoCAD, and one compared four smile design programs by how dental specialists and laypeople ranked them. None of the listed author affiliations is SmileFy, and none of the abstracts says who funded the work.
AI vs. expert designs (Dentistry Journal, 2026). A prospective paired study of 33 patients, by researchers from universities in Egypt and Saudi Arabia, compared a fully automated SmileFy design with one made by hand by an experienced clinician in exocad. Twenty blinded prosthodontists rated the designs. SmileFy designs had lower total Dental Esthetic Screening Index (DESI) scores (14.79 vs. 18.73), and both the prosthodontists and the patients gave them higher visual analog scale ratings. Patients preferred the SmileFy design in 69.7% of cases and the expert design in 30.3%. Mean design time was 30.82 minutes for the AI workflow and 63.48 minutes for the expert one, a 51.46% reduction, the abstract reports. The authors describe AI designs as potential adjunctive tools in esthetic treatment planning.
Accuracy against exoCAD (Journal of Esthetic and Restorative Dentistry, 2026). Researchers at Cairo University, Azhar University and Newgiza University in Egypt designed 10 esthetic cases twice, once in SmileFy and once in exoCAD, and superimposed the two designs to measure the difference. SmileFy showed an average error difference of 0.29 ± 0.095 mm. Dentist and patient satisfaction did not differ in a statistically significant way overall, but exoCAD was preferred for secondary anatomy. The authors conclude that SmileFy “shows promise but requires further refinement”.
Aesthetic preference across four programs (Journal of Prosthodontics, 2026). A cross-sectional study from Riyadh Elm University in Saudi Arabia ran photos of 10 standardized models through SmileFy, Smilecloud, DTS PRO and Trios Smile Design. One prosthodontist reviewed each automated output and adjusted it where needed, so the authors call the results AI-assisted. 78 dental specialists and 86 laypeople ranked the four outputs, blinded to the software. SmileFy had a mean rank of 1.78 out of 4, Smilecloud 1.90 and Trios 3.55. The abstract says the letter mapping used per set was not formally logged and that the findings should be read as associations.
These studies measure how designs look and how long they take to make. None measured treatment results, and they don’t test the vendor’s 60-second or 98% figures. The 33-patient study’s design time of about 31 minutes covers the whole AI workflow it recorded, which is a different measure from the vendor’s photo-to-plan claim.
FDA status and privacy
We found no FDA listing for SmileFy. We searched the FDA’s 510(k) database (which includes De Novo numbers) and PMA database through openFDA on October 20, 2026, by applicant and device name, and found no entry under SmileFy’s name. The vendor’s saved pages make no FDA claim either way.
On privacy, neither saved page (home and pricing) mentions HIPAA, a BAA or security. The pricing page links to a privacy policy that we did not save. SmileFy handles patient photos and intraoral scans, so ask the vendor for a signed BAA and its security documentation before you upload patient data.
Pricing
SmileFy pricing starts at $1,299 a year for the Starter plan, on the vendor’s pricing page checked October 20, 2026. Each plan can be paid monthly or yearly, and the page says yearly billing saves about 16%.
- Starter: $1,299/year or $129/month. Unlimited AI smile simulations and AI smile videos, 1 user, onboarding training and premium support.
- Professional: $2,599/year or $259/month. Everything in Starter plus unlimited 3D smile design and STL exports, the AI Articulator and the All-on-X design workflow. 1 user.
- Enterprise: starting at $2,500/month, based on requirements and usage volume, for DSOs, labs and multi-clinic groups. Adds the APIs, custom reporting and enterprise deployment.
- Design4Me credits: 1 credit for $100, 5 for $475 or 10 for $900.
Elsewhere on the same page, SmileFy says “SmileFy Plan starts at $999/year”, which doesn’t match the lowest plan price it lists ($1,299). Ask which price applies before you buy. SmileFy also argues that one cosmetic case pays for the subscription. That is its sales pitch, and we have no data to check it.
Who it’s for
SmileFy suits a general or cosmetic practice that sees veneer, bonding or smile makeover patients and wants a visual to show them at the consultation. The Starter plan covers simulations and videos only. If you also want to design and print mock-ups or temporaries in-house, you need Professional, and Design4Me covers cases you’d rather hand off.
Look elsewhere, or ask more questions first, if you need a signed BAA up front, an FDA-listed product, integration with your PMS, or several users on one account below the Enterprise tier. The saved pages don’t offer any of those.
FAQ
Is SmileFy FDA cleared?
We found no FDA listing for SmileFy. A search of the FDA’s 510(k) and PMA databases on October 20, 2026 returned no entry under the vendor’s name, and the vendor’s saved pages make no FDA claim.
How much does SmileFy cost?
SmileFy starts at $1,299 a year or $129 a month for the Starter plan, per its pricing page checked October 20, 2026. Professional is $2,599 a year or $259 a month, and Enterprise starts at $2,500 a month. Outsourced Design4Me designs cost $90 to $100 per credit depending on the pack.
Does SmileFy work with my intraoral scanner?
SmileFy says it works with any intraoral scanner. The saved pages don’t name scanner brands or file formats, apart from STL for the Enterprise design API. Ask for a test with a scan from your own scanner during the demo.
Is SmileFy accurate?
Three small 2026 studies looked at it. A 10-case study from Egypt measured an average difference of 0.29 ± 0.095 mm between SmileFy and exoCAD designs, and a 33-patient study found patients preferred the SmileFy design in 69.7% of cases. None of the studies measured treatment results.
Can SmileFy plan treatment without a dentist?
No. SmileFy produces simulations, a suggested plan and designs; the treating dentist decides what is done. The saved pages don’t describe an approval step, so ask how designs are reviewed before export.
Does SmileFy sign a BAA?
The saved pages don’t say. Neither the home page nor the pricing page mentions HIPAA, a BAA or security, so ask SmileFy directly before you upload patient photos or scans.
How this review was put together
We didn’t use SmileFy. This review is built from SmileFy’s home and pricing pages (both needed a browser to render, and the home page had little text), a search of the FDA’s 510(k) and PMA databases through openFDA, and a PubMed search for “SmileFy” in titles and abstracts, which found three studies. We read the abstracts, not the full papers. We did not collect user reviews for this tool, so there are no user ratings or user comments here. All sources were checked on October 20, 2026.
Sources
- SmileFy: home page, accessed October 20, 2026
- SmileFy: pricing page, accessed October 20, 2026
- openFDA device 510(k) and PMA databases (search for “SmileFy”), accessed October 20, 2026
- PubMed search: SmileFy[tiab], accessed October 20, 2026
- Clinical and Patient Comparison of AI and Expert Digital Smile Design: A Prospective Paired Study. Dentistry Journal, 2026, accessed October 20, 2026
- Artificial Intelligence Versus Conventional Methods in Digital Smile Designing: An Accuracy Study. Journal of Esthetic and Restorative Dentistry, 2026, accessed October 20, 2026
- Comparative evaluation of artificial intelligence-assisted smile designs: Aesthetic preferences among dental specialists and laypeople. Journal of Prosthodontics, 2026, accessed October 20, 2026
