3Dresyns is globally the first and only 3D resin supplier selling "monomer free" biocompatible 3D resins, colors and additives with Material Safety Data Sheets (MSDSs) with non toxic raw materials and without any toxicity risk hazard pictograms. Our "monomer free" reactive resins do not contain any monomers as supplied. They have been designed to reduce the risk of monomer extraction. On the other hand, our monomer based 3Dresyns use safe bio monomers for maximum safety.

Why some "biocompatible" monomer based 3D resins can be toxic before and even after printing and postprocessing?

Let´s review different findings published in academia about the toxicity of some commercial 3D resins even after printing and postprocessing: 

Fig. 2

As clearly highlighted in the last mentioned scientific paper published by the Northwestern University (Chicago, USA), Formlabs’ Dental SG and LT Clear printed in Form 2 SLA 3D printer were toxic, despite being certified as biomedical devices.

This publication "The Biological Effects of 3D Resins Used in Orthodontics: A Systematic Review" concluded that although these resins are considered biocompatible, they exhibit reproductive toxicity in mouse oocytes after direct and indirect exposure. The tested resins were Formlabs Dental SG resins (DSG) and Dental LT Clear (DLT), classified as biocompatible for medical use and currently used in dental surgical guides and oral retainers. 

Conclusions: Within the scope of this review, it was noted that studies evaluating the biological effects of 3D resins in orthodontics are mostly conducted in vitro. Although mixed results are described, 3D printed aligners may present higher levels of cytotoxicity and genotoxicity when compared to thermoplastic resins, particularly those that have not been subjected to a final surface treatment. As such, clinical studies analyzing saliva, blood, or even urine samples must be carried out in the future to determine the levels of monomers released in humans upon the use of these devices.

In this publication: Evaluation of dimensional accuracy and degree of polymerization of stereolithography photopolymer resin under different postpolymerization conditions: An in vitro study the degree of polymerization of a Clear Formlabs 3D resin was evaluated following Formlabs printing and postprocessing protocol. Several specimens were cleaned with isopropanol in the Form Wash unit (Formlabs) for 15 minutes to remove excess resin and poscured with Formlabs light box Form Cure at 15 and 30 minutes and at 40, 60, and 80 ºC. The results are shown in the following table:   

 

Polymerization (%) of photopolymer resin under different postpolymerization conditions as determined by Fourier transform infrared spectroscopy. Different letters indicate significant differences among groups (P<.05).

The degree of polymerization for all the postprocessing conditions is in between 70 and 90%, which confirms that the % of residual uncured monomer is between 10 and 30%. The % of residual uncured monomer is extremely high and can leach out from the prints and be absorbed by humans, causing potential cytoxicity, genotoxicity, and potential health problems.

The Quality requirements of class I & II biomedical devices, including dental devices, such as FDA, ISO 20795, 13485 & 10993, limit the residual monomer content  to <0.1%, which is much far below the 10-30% already reported. The residual monomer in liquid state is trapped inside the solid printed device and is prone to leach out, be extracted by saliva, and absorbed by the mucosa. 

Which is the risk of trapped residual monomers in printed devices for human health? The answer depends on the type and concentration of physically trapped monomers, leachables, and extractables in the medical devices.

How can the risks for humans be figured out? By reading the MSDSs of the liquid 3D resins as supplied, and the individual risks and hazards of their monomers, and other ingredients since they are leachable, and extractable if uncured or physically trapped "non bound" to the device.  

Similarly to the previously reported findings, the resin of Graphy for direct printing of aligners also may raise concerns on potential health hazards as reported in this paper published in the European Journal of Orthodontics: Leaching from a 3D-printed aligner

"Although efficiently polymerized and BPA free, the great variability in the amount of UDMA monomer leached from the examined samples may raise concerns on potential health hazards after repeated intraoral exposure"

3Dresyns statement:

The biocompatibility failure of the mentioned commercial resins might have happened to any biocompatible resin, even to the most biocompatible resins if and when would not had been properly printed and postprocessed.  

Biocompatible 3Dresyns

Discover our Biocompatible 3Dresyns:

Our Biocompatible 3Dresyns comply with the Quality requirements for Class I, IIa & IIb and III of FDA of ISO13485 and ISO10993 for the manufacturing of medical devices.
Our monomer free biocompatible 3Dresyns are ultra pure "reactive photopolymer" systems with reduced extractability, lixiviation and cross-contamination potential health problems occuring with existing competitive monomer based systems.
3Dresyns contribution to the biomedical market is crucial to ensure maximum safety of 3D printed medical devices. The biocompatible 3D printing materials market is growing significantly and our goal is to actively develop safer and safer materials.

Learn more about the highest safety standards of our Biocompatible 3Dresyns:

Customisation

3Dresyns custom designs biocompatible 3D resins, postprocessing protocols, and quality controls to meet the most demmanding specifications, without hazards, nor risks, for printing safe biomedical devices, food packaging, and toys.

    You may contact us to consult about our customisation services of biocompatible synthetic and bio-based 3Dresyns and your specific performance goals at: info@3Dresyns.com

    Learn more about Certification of biomedical devices and food packaging