Questions (Q) and Answers (A) about 3D printed biomedical and dental resins:
Q1: Do you supply 3D resins for printing biocompatible medical devices, as well as for dental and orthodontics?
Q2: Are your 3D resins certified?
A2: Our resins are compliant with the quality requirements of the applications for which have been intended. Certification is required for medical devices, not for their raw materials as supplied. Fore more info read: About Certification of biomedical devices and food and pharma packaging
Q3: Can I use certified resins and avoid the certification of my 3D printed medical devices, including dental and orthodontic devices?
A3: Certification of any sort of medical devices is required before trading them. Reliance on certified 3D resins does not exempt you from certifying your medical device and your production process
Q4: Are certified resins safer and more biocompatible than non-certified but compliant 3D resins?
A4: No, since certified resins do not ensure nor guarantee that medical devices are safe for use since certification is required to 3D printed medical devices, not to its basic raw materials before their printing and postprocessing. Additionaly, certified resins cannot be tuned nor adjusted to different printing specifications since their compositions cannot be adjusted to meet the printing requirements of different printer specifications
Q5: Why some 3D resins are certified while others are not?
A5: Some suppliers certify their 3D resins as being medical devices causing confusion in the market. Unfortunately, some 3D printer users have used them to avoid getting their own certifications compromising consumer health protection
Q6: Why certified 3D resins cannot guarantee that my 3D printed medical devices conform with the Medical Device Regulation MDR?
A6: Because "certified" 3D resins are not medical devices, but raw materials which need to be tuned, printed and postprocessed properly with the appropriate design, equipment, and quality control to conform with the regulatory, the MDR in Europe, and the FDA in USA, for producing safe medical devices
Q7: Why medical device manufacturers have to certify their 3D printed medical devices when the instructions for use supplied by certified 3D resins suppliers are strictly followed?
A7: On one hand, the existing certified 3D resins in the market have certified their products but not their instructions for use in detail, nor the equipment nor controls required for producing safe 3D printed medical devices. On the other hand, presuming the whole production workflow, including the resins, equipment, quality control, maintenance and the whole production protocols and workflows had been certified, this would just evidence that the 3D resin printed and postprocessed with certain equipment and quality controls may conform and comply with certain standards, such as ISO 10993, or the FDA, and with the regulatory, such as the EU Medical Device Regulation MDR 2017/745. Compliancy with the regulatory of certain medical device system does not ensure nor guarantee that its replication, with similar or other printed design and size of prints by third parties "printer users/medical device manufacturers", results in conforming medical devices, since manufacturing quality needs to be assured and validated in house for each batch, equipment calibration and maintenance needs to be assured, as well the prevention and correction of any potential non-conforming variables to ensure the production of safe validated medical devices
Q8: Is legal to use non-certified resins for printing medical devices?
A8: Certified and non-certified but compliant 3D resins can be legally used presuming they comply and conform to the quality specifications of medical devices, once tuned, printed, and postprocessed properly with the right printer, printing and postprocessing equipment and workflows to ensure the production of safe compliant, conforming, and certified medical devices
Q9: Is there any difference in quality between certified and compliant 3D resins?
A9: Nor of them can ensure passing the different biocompatible testing for the medical application for which they may have been intended since passing the quality requirements of certain standard or regulation depend on the quality of 3D printed medical devices manufactured by medical device manufacturers, which is beyond the responsibility and control of 3D resin suppliers. The advantage of compliant 3D resins is that they can be adjusted and tuned to different printers and printing settings, to maximise the safety and quality of medical devices. For more info read: Health & Safety concerns of "certified" 3Dresins
Q10: Which warranty can I have after purchasing biocompatible 3D resins of conforming to the specifications and quality requirements of different class of medical devices?
A10: 3D resin suppliers cannot ensure, nor grant any warranty, as a blank cheque, of certifiability since the quality and safety of any manufactured biomedical device it is beyond its competence and control. Nevertheless, 3D resin manufacturers are responsible for making resins compliant with the quality requirements of the claimed standards, for aiding manufacturers in getting the required certifications for making biomedical devices.Despite 3Dresyns Instructions for Use for general purpose applications do not need the understanding of any complex concepts and equations, printer users need to be trained and be skillful enough to prevent and resolve basic and sometimes complex printing scenarios. This is specially important when 3D printing medical devices, since medical device manufacturers, the printer users, are responsible for the quality of their products before and after commercialization.
3Dresyns Instructions for Use IFU for biocompatible resins explain with full detail the process for printing and postprocessing safe 3D printed resins for medical dental and orthodontic applications. Nevertheless, 3D resins suppliers cannot guarantee the properties and printability of their resins since biocompatibility, and the physical, mechanical, or any other properties are beyond 3Dresyns control.
Q11: I heard that some 3D printed resins can have a bitter taste when used in dental and orthodontic applications. What is the reason and how can it be avoided?
A11: Most liquid 3D resins as supplied have a bitter taste which disappears after full curing and cleansing. Additionally, most biocompatible 3D resins as supplied, and even after printing, may cause irritation and other risks and hazards when are not properly designed, printed, post cured, cleansed, and post processed. 3D printed medical devices may have a residual bitter taste in the mouth if the polymer conversion (conversion from monomer to polymer) is not high enough and when they have not been cleansed and post processed properly. When polymer conversion is below certain threshold, unreacted monomers and other leachables and extractables may provide some bitter taste and cause potential health hazards (unless they are fully removed before use) to users of dental and orthodontic devices. The full elimination of any residual leachables and extractables needs to the ensured by medical device manufacturers by implementing appropriate postcuring and cleansing protocols and workflows, to ensure that polymer conversion is maximised and that any potential leachables, extractables, and cross-contaminants are removed from the medical devices before use.
Q12: Is it possible to optimise the biocompatibility properties of 3D resins to different printers and postprocessing equipment?
A12: Yes, optimisation of the printing speed and dimensional accuracy is recommended and required for manufacturing high quality medical devices. 3Dresyns supplies a whole range of photocatalysts "photoaccelerants" and "resolutioners", for custom optimisation of 3D resins for the different specifications of commercial printers and postprocessing equipment. 3Dresyns provides around 50 functional additives and around 20 functional modifiers for custom control of performance properties, which can be pre-added to supply ready to use 3D resins or can be post-added by our customers
Q13: Do you offer technical support services to help bustomers to manufacture medical devices?
A13:Yes, we offer 3D printing consulting services to help customers to design printing and postprocessing systems for passing different certification standards (class I, II, III, etc)
Q14: Do you develop bespoke biocompatible 3D resins for different medical applications?
A14: Yes, we offer 3D resin customisation services to ensure that 3D resins formulations meet the safety and quality standards for passing different certification standards (class I, II, III, etc)
Q15: Can you recommend me a reliable printer for printing medical devices?
Q16: Why do not you certify your 3D resins?
A16: We do not certify our 3D resins for several reasons:
- to comply with law since affixing CE marking (and certifications) to non-conforming products, such as 3D resins used for making medical devices is considered as "placing on the market unsafe non-conforming products or products to which the CE marking has been affixed falsely or in a misleading manner
- to avoid being complicit deliberately with non-conforming malpractice
- to have full freedom of tuning and adjusting 3D resins to different printing technologies, printer and post processing systems, for the different types of medical device specifications
- to ensure that the compositions of 3D resins are continuously improved and replaced with safer alternatives to ensure that in case classified "safe" compositions are eventually reclassified as "unsafe" by REACH
- to prevent compromising the safety to humans and to the environment since certified resins cannot be chemically modified, nor updated with safer raw materials unless their certification is re-evaluated
Q17: Am I legally covered by using 3D resin certications instead of certifying myself my own 3D printed medical devices?
A17: Legally medical devices manufacturers, including dental and orthodontic devices, need to certify their 3D printed products, facilities and production processes and ensure that they meet all the applicable requirements before their product are sold.
Non certified 3D printed medical devices cannot be legally sold in the market. The sale of non-certified medical devices is illegal and subject to fines and penalties protected by the laws of the country where medical devices havw been commercialized without certification.
Health problems caused to consumers by certified and non certified medical devices are subject to iatrogenesis lawsuits.
Medical device certification is regulated by the FDA in USA and the MDR in EU, which main objective is to help ensure that unsafe or otherwise non-compliant products do not find their way to the market.
For info read:
Q18: Can any 3D resin printer and light box unit be used for printing and postcuring 3D printed medical devices?
A18: The manufacturing of 3D printed medical devices, including dental and orthodontic devices, require reliable calibrated and well maintained printers and light post processing units without any light power variability, as well as professional technicians, practices, and protocols. Not all the commercial printers and light boxes meet the minimum specifications for printing medical devices.
Too low power and variable "non-controlled" power printers and light boxes can compromise biocompatibility and consumer safety since the % of leachable and extractable uncured monomers can be too high and "uncontrolled" increasing the risk of causing health problems to consumers. The postcuring of opaque colored 3D printed medical devices is particularly compromised when postcured even with high and non variable power light boxes, since light penetration is reduced due to they high opacity of such 3D resin systems. For more info read:
- Power difference of DLP, LCD & MLCD printers and its consequences
- Effect of printers on biocompatibility, safety and mechanical properties
Q19: are your 3D resins FDA approved (FDA 510k-Cleared) in the USA, and CE marked and ISO10993 certified in Europe?
A19: The mentioned regulations are applied and required for selling medical devices in the mentioned regions of the World, but legally speaking do not apply to the ingredients of medical devices, specially when they undergo significant physical and chemical changes during the manufacture of medical devices, as it is the case with 3D printed medical devices, including dental and orthodontic devices, made with photo reactive 3D resins
Q20: Why some 3D resins suppliers CE mark and certify their resins as medical devices?
A20: Some resin suppliers CE mark and certify their 3D resins misleadingly to promote their products in the market. This exercise is prone to cause problems of consumer safety since any printer user without any certification can be induced to sell its 3D printed medical devices without any guarantee nor legal coverage. The EU regulation on product requirements and market surveillance indicates that it is forbidden to affix the CE marking (including certification) to products for which EU specifications do not exist or do not require the affixing of CE marking (or certification): "placing on the market unsafe non-conforming products to which the CE marking has been affixed falsely or in a misleading manner.”
For more info read:
- About FDA´s Technical Considerations for Additive Manufactured Medical Devices
- About 3D Printing Medical Devices at the Point of Care
- About Certification of biomedical devices and food and pharma packaging
- Responsibilities of manufacturers of 3D resins for medical uses
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