October 13, 2021 4 min read
A “3D printing fever” has taken over the dental industry and it’s not a surprise, considering that permanent restorations can be produced with a material input as low as $2. Behind these innovations are companies committed to high-quality biocompatible 3D printing results with every print, such as BEGO and Ackuretta.
While the equipment has become increasingly easy to use for any dental professional, the need for a thorough education on the “How to use…” front has become even more important. Thomas Kwiedor, Head of Business Development for 3D Printing at BEGO, joined us for a conversation discussing some of the most frequently asked questions about 3D printing materials and the proper post-printing procedures.
As much as I love the sun, and despite the tremendous power and all the positive effects that come from sunlight – "natural healing" is not indicated in the context of dental applications.
To ensure reproducible results for medical products in terms of patient safety, all components for the manufacturing of dental restorations (including post-processing) are coordinated and tested – a time-intense process, which should be performed and overseen by experts. For this reason, only the recommended light-curing devices and the material-specific instructions of the manufacturers on the respective curing times should be used.
We should perhaps illuminate the difference between calibration and validation.
In contrast to calibration, i.e. the measurement and, if necessary, adjustment of the printer, the verification, and validation of a 3D printing resin for dental applications involves much more than just calibration. Extensive tests such as tooth fit tests or biocompatibility tests, etc. under specified conditions (e.g., temperature) are part of the process, as is ensuring the reproducibility of the results. To meet the legal requirements and all standard requirements, the manufacturers spend weeks and months to fulfill the extensive requirements for obtaining product approval.
IFU is the abbreviation for Instructions for Use. IFU means the information provided by the manufacturer informing the user of the intended purpose and correct use of a product and any precautions to be taken.
For example, when we talk about IFUs for 3D printing resins, they also include basic information about the handling of equipment and materials required to produce an approved (medical) product, i.e. the dental restoration made from the resin. Instructions for use for medical devices are subject to strict regulatory requirements as part of the product identification (labeling).
If you use 3D printers in your office, you should ensure that you are aware of the IFUs of all your equipment.
Whether it is possible to clean the printed objects with water or with IPA (Isopropyl Alcohol) depends on the chemical composition of the resins. With regard to our 3D printing materials, IPA has proven to be a reliable cleaning agent and leaves a clean solvent-free surface after cleaning, which is beneficial to product quality. Of course, the instructions for use should be followed and IPA should not be handled with bare hands.
Your customers are absolutely right with this statement. Is that why I would recommend that they do it?
The answer is no.
Before joining BEGO more than 11 years ago, I myself worked for many years as the managing director of large laboratories and am also a qualified auditor.
I am therefore very familiar with the regulatory requirements for medical devices, which have increased significantly in recent years. These requirements serve patient safety and are monitored by the respective authorities. It’s a multi-tiered approval process that can take years to fulfill.
So why should users invest significant time and financial resources to release validated processes when their industry partners already offer them validated solutions and the corresponding assurance to meet the necessary requirements.