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Erik Borgwardt

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Safe and effective digital dentistry products on the US market

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Premarket Notification, also known as the 510(k) process, is one of several controls to ensure that all medical devices that enter the American market are safe and effective. In this blog article, I will introduce you to two of the most common regulations as well as describe Elos Medtech’s journey towards bringing our full range of digital dentistry products to the US.  

Regulations to ensure safety and effectiveness of medical devices

There is an extensive system to regulate which products enter the US medical device market. United States Food and Drug Administration (FDA) is responsible for promoting and protecting the public health by ensuring effectiveness and safety of medical devices. The agency is also responsible for promoting innovations that improve medical devices as well as helping the public access scientifically based information about the products.

FDA divides medical devices into three different classes, based on the level of control needed to assure safety and effectiveness. This is dependent on the device’s design complexity, characteristics of use and the risk of harm if it is misused. Medical devices that belong to Class I, such as elastic bandages and examination gloves, are subject to the least regulatory control. Class II and Class III medical devices include products that are subject to more controls and approvals to ensure safety for the user and patient.

Premarket Approval vs. Premarket Notification

There are two major processes by which medical devices enter the US market after review by the FDA. The first one is the Premarket Approval (PMA). This process evaluates Class III medical devices that support or sustain human life, that are of great importance in preventing impairment of human health or present a potential, unreasonable risk of illness or injury. Examples of Class III medical devices are implantable pacemakers and pulse generators. Because of the risks associated with Class III medical devices, the PMA is the most stringent pathway of the two and it generally takes clinical trials to ensure the devices’ safety and effectiveness.

The other and most common way of bringing a new medical device to the American market is the “Premarket Notification” process which applies when a PMA is not needed. Premarket Notification, also called the 510(k) process, requires that a new medical device is compared to another already lawfully marketed model. The parameters that are compared are for example indication for use, material, chemical composition and design. The new device will get a 510(k) clearance by going through general controls, tests or literature search that show FDA that the device is at least as safe and effective as the predicate device it was compared to. This, in turn, means that the medical device manufacturer or their contract manufacturer can legally market and sell the device in the US.

A 510(k) clearance as a first step towards the complete digital workflow

Elos Medtech has been offering scanning abutments and model analogs on the US market for many years. Since they are categorized as Class I medical devices they do not require 510(k) clearances. The products are included in digital dentistry but they do not alone enable a complete digital workflow. For our customers to experience all the possibilities and benefits that digital dentistry has to offer we have been working on bringing more of our Elos Accurate products to the US market.

Just recently, we got a 510(k) clearance on our first Abutment Blank after a process of clinical testing and literature search. This does not only mean that the product itself is proven safe and effective, it also has a bigger meaning. Even though this is merely one step on the journey towards offering our full range of products for a digital workflow, it is a step that will pave the way for the next ones. Since we can now use the Abutment Blank as our predicate device in the Premarket Notification process it will accelerate the process of bringing our other products to the market. Next, we will focus on making our titanium bases available in the dental libraries for our American customers.

Meet up with Elos Medtech at LAB DAY Chicago

For the seventh time, Elos Medtech will exhibit at LMT LAB DAY Chicago, the largest international gathering of the dental laboratory community in the US. Between February 23-24 you can meet us at the event to get to know more about our upcoming product launches and developments. We are looking forward to seeing you there!

I hope you enjoyed reading this blog article about our ongoing work to provide dental professionals in the US with more of our digital dentistry products! For more information and news from the dental industry and Elos Medtech, visit our Dental blog!  

3D-printing and digital models in the dental industry

Great benefits of using 3D-printing and digital models in the dental industry

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3D-printing and digital models are gaining momentum in the dental industry. As a part of the digital workflow, 3D-printed models enable a more efficient workflow for dentists as well as dental technicians. Also, the method often results in more accurate end-results, beneficial for the patients. Stefan Remplbauer at 3D Medical Print produces 3D-printed models on a daily basis and is confident that 3D-printing and a digital workflow is the future within dentistry.

Hi, Stefan! How and when did you start working with 3D-printed models?

Back in 2012, I was working as a dental technician in my own lab. I did a lot of work using the digital aligner technology and I was struggling to find good quality printed or milled models to work with. I looked everywhere and tried out countless models offered from various companies. However, I could not find a company that produced models that were exact enough to get good results in the aligner foils. That was when I decided to produce the models myself. The printed models you could buy back then had poor quality, and the milled models were often inaccurate. Since those options were out of the question, I started looking for a 3D-printer that would meet my quality needs and allow me to produce models for a reasonable price. So, in December 2012, 3D Medical Print was founded and I started producing 3D-printed models in January 2013.

That is impressive! Can you tell me more about 3D Medical Print?

Yes, 3D Medical Print is located in Lenzing, Austria, and our main customers are dental technicians and dentists. As a dental technician with years of experience working with dentists, I am well aware of the needs of both parties. When contacting us, dental technicians are looking for a precise model with the right dimensions, which they can work a long time with without wearing it down. For dentists, 3D-printing offers surgical drill guides, which are printed from a biocompatible material. These guides reduce the risk of hitting a nerve while drilling, enhancing safety for both the dentist and the patient.

What are the advantages of using 3D-printing in the dental industry?

Compared to a plaster model, a 3D-model is a more stable, durable and precise alternative. The lines and edges on a 3D-model stay sharp without the dental technician having to worry about wearing them down. Compared to a milled model, a 3D-printed model has a more complex structure with a higher level of detail. 3D-printed implant models are definitely our best selling product at the moment. They come with high-quality removable dies and a unique flexible and removable gingiva mask. The gingiva mask is made of a soft, gum-like material, which lets the dental technician perform the work almost as if it was done directly in the patient’s mouth.

One of the most important advantages with 3D-printing is definitely that it saves the dental technician a lot of time. After the dentist has performed an intra-oral scanning on the patient, the dentist sends a digital copy of the scanning to a dental lab or a 3D-printing company. The digital copy is received in minutes, since it is sent electronically. The technician can start working as soon as the copy of the scanning  arrives. Also, it provides a clean workplace for the technician, without having to deal with plaster or inhale grinding dust.

Although 3D-printing has been around for more than 20 years, it is fairly new to the dental industry. However, the field of 3D-printing in the dental industry is growing wider and wider, and I believe the development of 3D-printing is the most exciting development in the industry today. The additive production process of 3D-printing brings numerous advantages and opportunities when creating dental products.

That sounds promising! How does 3D-printing benefit the patient and the end-result?

3D-printing is a part of the digital workflow that is becoming more and more common in the dental industry. A digital workflow starts with the dentist taking an intra-oral scanning of the patient’s mouth before sending the scanned copy to a dental technician. The intra-oral scanning is more patient-friendly than the conventional method of letting the patient bite in the impression material, which most patients find unpleasant and sometimes even nauseating. In addition, the conventional method can affect the imprint in a negative way depending on for example how long the impression material is left in the mouth.  

Besides giving the patient a more comfortable experience, a digital workflow ending with a 3D-print often results in a more accurate end-result, leaving out possible mistakes and inaccuracies that can easily come with conventional impressions.    

Can you describe your cooperation with Elos Medtech?

First and foremost, we are very proud of our cooperation with Elos Medtech. We have bundled our experiences in the dental industry and formed our cooperation together, which resulted in Elos Accurate® Model. The model is a high-quality implant model with a gingiva mask, a removable neighbour tooth and one original Elos Medtech analog already fitted into the model, offered for a package price.   

I think Elos Medtech has great products thanks to their design philosophy. I visited their production last year and I was really impressed by the fully open and structured workflow. Elos Medtech has a wide digital product portfolio and is focused on the development of new innovative digital solutions. For us, our cooperation with Elos Medtech was a step in the right direction. Since the field of digital dentistry and dental 3D-printing is quite young, it is always valuable to exchange ideas, thoughts and problems with specialists in the same field. I believe we complement and learn from each other, which in the end always benefit our customers.

To sum it up – how does the future look like for 3D-printing in the dental industry?

3D-printing is definitely the future of the dental industry. 3D-printing offers many opportunities and a lot of new exciting ways to make life easier for patients, dentists and dental technicians. Also, 3D-printing could be used for many more things that we do not even think of yet. For example, it could be used for guided sinus elevation and operation planning. They already use 3D-printed models of organs to simulate and plan risky operations beforehand, and I am sure this will be a part of the future in the dental industry as well.

The future of 3D-printing in the dental industry goes hand in hand with the development of digital dentistry and a digital workflow. The imprint of the patient’s mouth must be sent to the dental technician digitally to be able to transform it into a 3D-model. Luckily, the digital workflow is becoming more and more common and we are very excited to see where the road will take us. My own dream is to 3D-print a colour model, that looks exactly like the intra-oral scan with its real colours.

That sounds like a great thing to look forward to. Hopefully, your dream comes true! Thank you, Stefan, for a lovely chat.

I hope you enjoyed reading my interview with Stefan about 3D-printing and digital models in the dental industry. Would you like to know more about digital dentistry and the digital workflow? Do not miss our blog articles: