Analog Is Not the Opposite of Digital
You’re Doing it Wrong.
Many of us in the dental field have been using the word ‘analog’ improperly. We often refer to analog technologies as being anything preceding digital technology. That’s definitely not the case. So this post is to collectively save us all from ever sounding stupid to technology nerds ever again. And don’t worry, it’s not just us, I’ve seen the same mistake made in the New York Times.
I recall a video that referred to 1950’s classrooms as ‘analog learning’ as opposed to our modern classrooms’ use of computers and the internet. I’ve heard the work of contemporary digital artists and designers compared to the ‘analog art’ of painters. The real kicker, and reason for this post, is those who position traditional handmade work as the ‘analog’ opposite of digital dental technology.
Handmade isn’t Analog.
Restorations that are handmade are not analog, period. As an analogy, I recently picked up a used Canon Rebel G from the ’90s used to shoot film. I have had a digital SLR from Canon for years now, and they’re obviously extremely different. But we have to be careful not to confuse ‘old’ and ‘new’, with two very specific terms like analog and digital.
The word digital, to most people, refers to a device that can capture, store, or display data in a binary fashion. Ones and zeros, on and off, digital is all about numbers. Digital shouldn’t be confused with binary, of course, as digital simply means concrete values. The root word is digits, after all. Any system that utilizes solid values (or digits) is digital, binary is simply the most common system. Digital cameras, and conversely digital 3d scanners capture light with a sensor, that light is converted into data (numbers), so the use of the word ‘digital’ for your cell phone camera, DSLR, or 3shape is accurate.
Analog, however, is a very abused word. I would venture a guess that the significant amount of technicians have used the word ‘analog’ to refer to anything done traditionally. If the new, fancy robot 3D scanners are ‘digital’ then our aging techniques are ‘analog’, right? Not at all. Leaning back on the camera analogy: Older cameras capture light with film, which is basically plastic, gelatin, and silver halide. When you take a photo (perhaps of an aesthetic full mouth restoration), photons hit this material and produce a latent (invisible) image, that can later be brought into view by bathing the film in various chemicals. You could write hundreds of blog posts on film development alone, but the point is that film photography is a chemical process. Conversely, when you stack porcelain, or process a denture, the materials go through various chemical and physical changes.
Digital 3D scanners and traditional techniques are quite different, but I’d rather hear the word ‘chemical’, ‘organic’, or ‘magic’ given to traditional techniques before ‘analog’.
Wait, What is Analog Then?
Analog, as its name suggests, refers to being analogous to something. If we’re referring to the adjective used in technology, the definition of analog is:
Of, relating to, or being a device in which data are represented by continuously variable, measurable, physical quantities, such as length, width, voltage, or pressure. – Wordnik
So a great example of an analog technology would be a vinyl record. The audio is stored as waves (variable data) within the grooves of the vinyl. Digital audio stores the data as numbers, as finite units of data per second found in mp3s and CDs. What’s important is that a vinyl record is legitimately something that deserves to be called ‘analog’. Dentures are not. Dentures and the techniques used to fabricate them are physical and chemical, there is no data (waves or otherwise) to be found as there would be on the record.
Plenty of older (and current) technologies are analog. Just be sure to ask yourself if that device has variable signals/data, or if that device is just really old. A television with a cathode ray tube (CRT) is an analog device; a cave painting of a man stabbing a mastodon with a spear is not. Ironically, CNC machines and 3D printers take digital signals and use transducers, pulse width modulation (PWM), or variable frquency drives (VFD) to produce analog signals that drive the spindles or lasers that ultimately produce a restoration. Those restorations are technically physical “analogs” of their corresponding digital designs.
Stop Saying Analog?
I know its hip to be anti-digital sometimes. But before we all drink a PBR and hop on our fixed gear bikes to the thrift store, we have to remember that just because something is old, that doesn’t make it ‘analog’. 35MM cameras, oscilloscopes, and the cotton gin are all old technologies, but only one of them is an analog device.
We pride ourselves in the dental lab industry for knowing tons of interesting things about art, science, and technology, but this is one adjective we should all cut back on a bit. The good news is we will always have our favorite noun: analogue! We can still say: “A picture is an analogue of a memory”, or “A cubic zirconia is an analogue of a diamond”, and “Cerec is an analogue of real lab work.”
3D Systems and Amann Girrbach Join Forces to Expand Ceramill® Digital Dental Workflow with NextDent™ 3D Printing
Integrated single-source solution will enable dental labs and clinics to produce dental devices faster and more economically with lower total cost of operation
ROCK HILL, South Carolina and KOBLACH, Austria, October 22, 2018 – 3D Systems (NYSE: DDD), the originator of 3D printing, and Amann Girrbach, a leading supplier of digital dental prosthetic solutions, today announced that Amann Girrbach will be integrating 3D Systems’ NextDent™ 5100 3D printing solution into its Ceramill® System digital dental workflow. This will allow the Austrian-based company, which has partners in over 90 countries worldwide, to offer its thousands of dental lab customers an expanded integrated solution that combines dental-optimized 3D printing with its suite of CAD/CAM software, digital milling and testing equipment.
Powered by 3D Systems’ proprietary Figure 4™ technology, NextDent 5100 is a complete 3D printing dental solution that produces precision trays, models, surgical guides, dentures, orthodontic splints, crowns and bridges at print speeds up to 4x faster and at significantly reduced cost compared to competitive systems. It supports the industry’s most extensive dental materials portfolio with 30 unique biocompatible and CE-certified NextDent materials available to cover a broad range of dental applications for lab managers, dental technicians, dental prosthetic technicians and clinical prosthodontists and orthodontists. 3D Systems 3D Sprint™ software provides a single interface for file preparation, editing, printing and management, and is now fully integrated with the Ceramill CAD/CAM workflow.
“With the addition of 3D Systems’ NextDent 5100 3D printing to our Ceramill System, we can offer our customers a more feature-rich digital dental workflow that will make them more competitive and efficient,” said Christian Ermer, Head of Product Management at Amann Girrbach. Amann Girrbach. “For example, a dental model is an important part of the restoration process and now with the Next Dent 5100 our customers can print their own models cost-effectively without having to move outside the Ceramill workflow. The NextDent 5100 can also produce bridges, crowns and even the full denture which dramatically lowers production costs and reduces turnaround time. This is certainly a win-win for our customers and their dental patients.”
“Additive manufacturing is transforming the way dental applications are planned, produced and delivered, due in large part to the wide variety of NextDent materials that are regulatory approved and clinically evaluated. We are pleased that Amann Girrbach, an industry leader in dental CAD/CAM solutions, is adopting our NextDent 5100 as the additive component in the Ceramlll workflow,” said Rik Jacobs, vice president, general manager, dental, 3D Systems. “Amann Girrbach’s customers are getting a trusted connection – a complete fast and accurate dental 3D printing solution that will work seamlessly with their existing Ceramill equipment and processes. This new partnership with Amann Girrbach is an important milestone in our strategy to redefine digital dentistry and demonstrate our ability to optimize production workflows.”
Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward looking statements can be identified by terms such as “believes,” “belief,” “expects,” “may,” “will,” “estimates,” “intends,” “anticipates” or “plans” or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings “Forward-Looking Statements” and “Risk Factors” in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise.
About Amann Girrbach
Amann Girrbach, one of the leading innovators and full-service provider in digital dental prosthetics, is championing the cause to enable a complete in-house process chain for its customers. As a result, labs profit from perfect quality frameworks, but also from efficiently arranged workflows, reproducibility and dependable processing and a sophisticated CAD/CAM material range. Thus, the Ceramill CAD/CAM system is one of the most versatile and technically adept on the market which incorporates 35 years’ experience and know-how in CAD/CAM. The high degree of inhouse production spanning the product idea up to final assembly allows Amann Girrbach to adapt its systems to economic and dental-specific requirements right from scratch.
Get more information about Amann Girrbach at www.amanngirrbach.com.
About 3D Systems
3D Systems is the originator of 3D printing and an innovator of future 3D solutions. It has spent its 30-year history enabling professionals and companies to optimize their designs, transform their workflows, bring groundbreaking products to market and drive new business models. This is achieved with the Company’s best of breed digital manufacturing ecosystem. It’s comprised of plastic and metal 3D printers, print materials, on demand manufacturing services and end-to-end manufacturing software solutions. Combinations of these products and services address a variety of advanced applications- ranging from Aerospace, Automotive, and Consumer Goods to Medical, Dental, and Jewelry. For example, 3D Systems’ precision healthcare capabilities include simulation, Virtual Surgical Planning, and printing of medical and dental devices as well as patient-specific surgical instruments. More information on the company is available at www.3dsystems.com.
Hey, whats up guys! Today we’ve got a special post for you. This article is written by Carbon and I thought it had some really great info so I reached out to see if we could feature it on this blog.
Huge thank you to Bryon and the team over @Carbon for letting us share it with our readers!
Additive Manufacturing of Dental Devices: A Primer on Regulatory Affairs
Digital dentistry has evolved from its beginning in the late 1990s. It started with the development of CNC machined crowns derived from digital scans of stone impressions and, by the mid-2000s, progressed to direct digital scans used to generate templates for thermoformed oral appliances. Current practice includes the direct fabrication of surgical guides and dentures and the promise of direct fabrication of aligners using 3D printing.
Carbon’s journey in this space began in 2017 with the release of DPR 10, a stone-colored material for rapid and accurate printing of dental models, with properties suitable for thermoforming models. This was followed by validation of third-party dental materials for surgical guides, custom trays, gingiva masks, and most recently, denture bases and denture teeth for printing on Carbon M Series printers. The growth of Carbon’s user base in dental and orthodontic laboratories has been nothing short of phenomenal. With that growth has come an awareness of the complexity of the regulatory landscape for dental materials, and for our customers’ readiness to meet those requirements. The goal of this white paper is to share our understanding of the current regulatory landscape of 3D printed dental devices.
This white paper is not intended as a substitute for obtaining your own advice regarding legal and regulatory matters, including all FDA regulatory matters. Carbon is not providing you any such advice in connection with this white paper, but rather a basic outline of the regulatory environment. The circumstances of any particular participant in this environment can vary widely, and you should consult your own advisors to obtain advice specific to your circumstances.
KNOW THE FDA BASICS
In general, the FDA does not regulate or approve materials, it regulates devices. Based on risk (Class I, II, or III), the FDA can clear a medical device for sale if (I) it demonstrates safety and is manufactured according to an appropriate quality management system, (II) it can be shown to be equivalent to an existing cleared medical device, or (III) can approve if it is a higher risk device that has had its safety and effectiveness established through more extensive pre-clinical and clinical studies. Since few dental devices fall into the third category, we will focus this white paper on low-to-moderate risk devices (the first and second categories).
Low-risk devices (no need to demonstrate equivalence)
Deemed as Class I, these devices cover items such as toothbrushes, and in digital dentistry include surgical guides, custom trays, and the like. For this level of risk the manufacturer only needs to have in place a quality management system (manufactured under current Good Manufacturing Processes, cGMP), and have data on the safety of the device (generally biocompatibility and mechanical performance data). The manufacturer (or a distributor) is required to register with the FDA and list the device(s).
Moderate risk devices (must demonstrate equivalence)
Deemed as Class II, these devices include denture bases, temporary crowns and bridges, mouth guards, and aligners. For these devices, the manufacturer or distributor must prove their device is “substantially equivalent” to a legally marketed device which has the same purpose (indication for use). Proving that equivalence is described below.
The 510(k) process (how to demonstrate equivalence)
Proving to the FDA that a new medical device is equivalent to an existing medical device (called a predicate device) is referred to as the “510(k) Clearance Process.” Here “equivalence” means the device must treat the same condition in the same way, and its manufacture or composition must not raise any new questions of safety and efficacy. The establishment of “substantial equivalence” (SE) to a “predicate device” allows a manufacturer to legally market their device in the US. Class I devices are exempt from the 510(k) requirements (Figure 1).
There are a few Class II devices that have been “down-regulated” and are exempt from the 510(k) process (“Class II exempt”). An example of this would be 3D printed denture teeth (FDA product code PZY). There are also a few devices that did not receive a risk category in 1976 when the Medical Device Amendments of the Food, Drug and Cosmetics Act were enacted. These fall under the “Unclassified” category, and most devices require 510(k) clearance for marketing (Figure 1). Relevant examples would be a mouthguard prescribed for migraine reduction (FDA product code OCO) or an over-the-counter mouthguard for treating tooth grinding (FDA product code OBR).
Figure 1: Simple process flow showing different FDA clearance requirements for a single “clear” material used for making different dental devices.
FDA APPROVAL: WHAT DOES IT MEAN FOR DIFFERENT STAKEHOLDERS?
First, the word approval applies to high risk medical devices. All lower risk devices are “cleared.” A claim of a dental material having “approval” by the FDA generally means that its been 510(k) cleared for some indication. Clearance for one indication by the FDA or any other regulatory body (for example a Class IIa designation of a device in the EU) does not carry over to any other indications for use.
We’ve said that the FDA does not regulate materials. Yet, it regulates the materials used for 3D printing of dental devices. The following quotes from FDA should also help clarify this fact.
“The materials that the dental branch clears are, in fact, finished devices that are patient matched at the point of care.”
“Dental materials are finished because, in their current state, they are capable of functioning when patient-matched by the end user.”
So, even though they are not the finished medical device, their purpose is to generate a patient-matched medical device. Hence the FDA’s decision to regulate the “starting material.”
What about manufacturers or distributors? Are they regulated?
A manufacturer or distributor of a 3D printing material capable of fabricating a finished device is regulated. A distributor could bring a device not cleared in the US into commerce in the US, but they would then have all the regulatory responsibilities (registration and listing, and if the device is Class II, submission of a 510(k) premarket clearance request).
What about the laboratories? Are they regulated?
This is a complex question. At Carbon, we are learning more and more about laboratories being FDA audited to see if they are adhering to good manufacturing practices. Laboratories have been exempt from registration but have been expected to be compliant with 21 CFR 820 (the FDA Quality Management Systems regulations). But as laboratories engage in more CAD/CAM and use regulated products, including regulated design software, they can veer into the realm of a manufacturer. If a laboratory modifies a design or uses software in conjunction with a material or a printer not validated by the software manufacturer (see below), or manufactures an oral appliance with a material not cleared for that end use, then the laboratory might be creating a misbranded (not appropriate for its indicated use) or adulterated (does not comply with appropriate standards) product.
To be in compliance with 21 CFR 820, a dental laboratory needs to be able to demonstrate to the FDA that it has in place current Good Manufacturing Practices (cGMP). Its beyond the scope of this white paper to describe these requirements, but there are many consulting services available to help dental laboratories put the required systems in place.
What about 3D printers? Are they regulated?
3D printers are not regulated because they are not finished medical devices. However, since the FDA regulates software capable of designing finished medical devices, the software developers work with both laboratories and printer manufacturers to validate the printers, materials, and post-processing ability to produce the finished device with required accuracy and final physical and safety properties.
Going forward, laboratories need to carefully consider their use of a 3D printing material for the manufacture of dental appliances. Using a dental material to fabricate a device for which it is not FDA cleared can potentially be of risk to patients and can open the lab to regulatory penalties. A material certified for use in Europe (Class IIa) might not be in the US, and vice versa. If you manage a laboratory, follow the guidelines on the label for each material, and get reliable regulatory advice to see if you need to register with the FDA. Manufacturers and distributors need to ensure their materials have the necessary approvals in the regions where these resins are sold.
Dental and orthodontic professionals, software developers, material developers, and printer developers are creating an increasing number of devices to enhance and improve patient oral health care. Carbon is proud to be a leader in this activity and your trusted partner on this journey.
For additional information on Carbon’s dental solution, send us a note at firstname.lastname@example.org.