Following the landmark news that Stratasys’ Truedent has received CE-mark certification as a class IIa medical device, we sat down with Shoshana Glickman and Negar Movahed to discuss why this regulatory milestone is a game-changer for UK labs.
Could you both briefly introduce yourselves and your roles at Stratasys, and for our readers who may be new to the brand, tell us a bit about the Stratasys mission?
Negar Movahed: I am the head of product at Stratasys Dental.
My role sits at the intersection of customer needs, technology innovation, and long-term market direction.
Essentially, my goal is to bring valuable products to the market that solve real problems for lab technicians, clinicians and, ultimately, the patients.
Shoshana Glickman: I’m on the dental marketing team at Stratasys, where we focus on getting the word out to dental labs about what our 3D printing technology can do – from improving lab efficiency and reducing labour to enabling scalability and delivering consistent, reliable quality.
At Stratasys, we are global leaders in additive manufacturing.
While many know us from the industrial or aerospace sectors, our mission in dental is to deliver fully validated, end-to-end solutions, opening the door to scalable, high-quality production for dental labs.
We’ve just seen the news Truedent has received CE-mark certification as a class IIa medical device. For technicians, what does this actually mean?
Shoshana Glickman: It’s a major milestone.
It means we’ve been held to a much higher level of scrutiny regarding technical documentation, biocompatibility and mechanical properties.
For the lab, it provides peace of mind. They know the entire material lifecycle – from raw materials to the final product in the patient’s mouth – is verified.
The class IIa certification also allows us to move into expanded indications like removable partial dentures (RPDs) with our new Truesnap workflow.
Truedent is an especially ideal material for RPDs as it enables close, highly customisable shade matching to existing dentition, a level of precision that is difficult to achieve with other three-dimensional printing solutions, such as the single colour DLP printing.
Negar Movahed: It also gives labs the green light for long-term intraoral use with expanded indications.
When a lab fabricates these medical devices for the dentist, they can do so with absolute confidence that the clinical safety and performance have been verified by an independent body.
There are a lot of bargain resins or counterfeits on the market right now claiming to be compliant. How does this certification separate Truedent from the ‘wild west’ of unverified products?
Negar Movahed: I love this question because it speaks to the heart of our discipline.
Stratasys is a conservative company in the best way possible.
As a large, public tech company with a dental vertical and relatively new to the medical device world – rather than a traditional dental medical device company – our approach is different, we make an intentional choice not to pursue risky loopholes.
Our leaders gave us a clear mandate to be conservative when it comes to safety, quality and patient safety.
Biocompatibility tests are incredibly expensive and they take time. That’s why some companies choose to use literature references instead of testing new formulations.
We completed the full battery of tests defined by an independent toxicologist, based on the device type, contact type and exposure duration, in accordance with ISO 10993, rather than selecting only a subset.
Partial testing can introduce unnecessary risk to the patient. You rarely see that level of commitment from other resin manufacturers.
A lot of these bargain companies you mention market a resin and say: ‘Put it in any printer, use any setting, the result is up to you’. That is a dangerous situation.
We take a different approach. We validate every single step of the workflow-material, printer, parameters and process – because patient safety and clinical reliability are non‑negotiable.
Why is that trust factor so critical right now for a lab manager looking to scale their business?
Shoshana Glickman: If you scale your production up to hundreds of units a month and then find out your material was non-compliant or has been pulled from the market, that can be a catastrophe for your business.
This certification gives labs the confidence to embark on scalable production of dentures and RPDs, knowing they have a recognised global standard behind them.
It reduces their legal liability and protects their reputation with the dentists they serve.
Can you pull back the curtain on the certification process? What hoops did you have to jump through to get the class IIa stamp?
Negar Movahed: It’s an exhaustive process.
Beyond the mechanical property testing (ISO 20795-1), we have to create a massive technical file. This includes an independent toxicologist – someone totally unaffiliated with Stratasys – reviewing our formulations and the size of the part going into the patient’s mouth. They define the testing plan, not us.
Then there is the quality management system (QMS) scrutiny.
Everything from our manufacturing process to our marketing claims has to be reviewed and approved.
It’s a level of oversight that ensures the product isn’t just ‘good’ from the manufacturer’s perspective, but consistently safe and effective with a stamp of approval from an independent third party.
Truedent is famous for its monolithic 3D printing – printing teeth and gingiva in one go. How does the technology itself help with the labour shortages in UK labs?
Shoshana Glickman: Polyjet technology is essentially like inkjet style 3D printing.
We print tiny droplets of different resins simultaneously.
This allows us to combine five base-colour resins in various ratios to create incredible, multi-shade aesthetics in a single print run.
Because it’s a monolithic print, there’s no manual assembly of teeth into a base.
Any time you introduce a human into that assembly process, you inevitably get variations.
With Truedent, the accuracy is locked in digitally. Plus, our J5 Dentajet has a large print tray but a small footprint.
You can set an overnight print, the nesting is automated with one click, and you walk in in the morning to find finished dentures ready for a quick water-wash.
It’s designed for labs that need to do more with fewer people.
Negar Movahed: It also fundamentally changes the try-in experience.
Historically, a try-in looked like a ‘white block’. With Truedent, the patient sees a highly aesthetic, full colour preview of the final denture.
It builds immediate trust between the clinician and the patient and gives the patient an instant gratification which you don’t get with other technologies.
Aside from eliminating the labour-intensive assembly of the denture teeth to the base, from a function perspective, monolithic printing addresses a known pain point: the risk of decoupling of the two during its useful life with the patient.
Because Truedent is printed as a single, integrated structure, patients do not have to worry about such failures during use.
With Truedent since it is printed all together, patients don’t experience losing a tooth on their denture!
LM: For the younger generation of technicians, how does this digital-first approach change the ‘art’ of the craft?
Shoshana Glickman: For the digital natives, this is incredibly exciting.
We use software called Grabcad, which is much more than just a slicer.
Technicians can design in Exocad or 3shape, and then apply characterisations and aesthetics digitally in Grabcad.
We are constantly releasing new software updates – which are free, by the way – that add new shades and features.
The art is still there; it’s just moved from the physical brush to the digital screen.
Negar Movahed: We have just launched our next‑generation advanced aesthetics capability with Truevoxel, taking Truedent polychromatic printing to the next level.
With enhanced translucency and characterisation built directly into the digital workflow, technicians can design truly life-like aesthetics with the simplicity of a click.
This launch gets us even closer to mimicking the natural smile that every denture patient wants to achieve.
Finally, is there anything else you’d like to add for the UK lab community?
Negar Movahed: We truly believe we’ve found the holy grail of dental 3D printing.
We’re not just launching a product; we’re launching a beautiful smile that gives patients the confidence to show it off.
With the launch of Truedent as a class IIa medical device, we have planned a dedicated roadshow for our European resellers and customers.
This means we are heavily investing in training the industry, from understanding the technology itself to mastering Truedent’s digital design techniques and clinical requirements, so labs can integrate Truedent into their workflows with confidence.
Our goal is long‑term success, not just adoption.
We have a strong roadmap of innovation ahead, and we are excited to continue sharing what is next with our industry partners.
Shoshana Glickman: Stratasys is fully committed to dentistry.
We are here to bring reliability, efficiency and trust to UK dental labs. Watch this space!
For more information contact Stratasys Dental at [email protected] or visit stratasys.com/dental.
This article is sponsored by Stratasys.
