3Dresyns dental resins are they certified for dental use?

Hi,

Has anyone any experience of using the dental materials from 3Dresyns? I am waiting on a reply from them to some questions regarding certification and quality assurance,

I can’t find any reference to them holding accreditation for a quality control system such as ISO 9001 or ISO 13485 (for example a certificate, as is published for the Formlabs materials) Has anyone seen anything that confirms their website claim

“Our Dental 3Dresyns OD comply with the Quality requirements for Class I, IIa & IIb of ISO13485:2016 for the manufacturing of orthodontic and dental medical devices.”

Also has anyone used their Cure-Tester and purification kit, does it really work as they claim?

From their website:

“Our new Cure-Tester and Purification kit is a fast, simple and reliable system for measuring the cure, postcuring and cleansing 3D printed SLA DLP & LCD resins. It is ideal for biomedical applications, including dental, to ensure that biomedical devices are safe for use”.

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Well I have just got up for breakfast and 3Dresyns have replied to my email to them. After reading the email I sent to them and their reply, my thoughts are is the certification such a mess? Is it really true that total responsibility is the end user?

As an end user how can I be certain if the resin coming from a supplier is consistent and has consistent quality if no officially recognised quality control system is in place by them? Equally do I just take their word that the resin will pass the required standards or do I (as an end user) have to test it each and every time - something that would be very expensive.

My thoughts are that its probably best to avoid them - especially if their responsibility ends as soon as the top is taken off the bottle.
How can I know if their test kit works properly and if it says its ok without testing it ourselves properly. With no quality control system in place for them how do I ensure that each test kit gives the same results.

We are not going to buy from them (I might reconsider if someone on here can give me a reason that says the approach of 3Dresyns is the right result, it hardly seems a professional approach to consistent quality or approval standards.

The email exchange and reply:

Info 3Dresyns to me

Dear REDACTED
We have the technology and materials which will meet your technical and safety specifications and fully comply with the technical requirements of ISO 13485 and FDA. Bear in mind, that we supply resins, not biomedical devices, consequently legally we do not need to be certified as a company, since the legal responsibility is for the producer/trader of the final medical device, once printed and post-processed.
We can help you to get the certification by consulting you to get the safest material and post-processing protocol, which will include the usage of these sort of cleansing systems:
https://www.3dresyns.com/products/3dresyn-cleaning-fluid
https://www.3dresyns.com/products/cure-meter-test-kit-for-measuring-the-cure-of-3d-prints

Unfortunaley, existing competitive resin systems do not usage any safe vpostprocessing protocols to ensure dental printed materials are safe for final users…In reality, consumers are in risk of absorbing residual monomers and byproducts…

As you know dental companies are relying on the accreditation of resin suppliers. From our perspective, after being legally advised, we concluded that there is no legal coverage to rely on raw materials suppliers certifications since the resins as sold are liquids, but are transformed to solids during the 3d printing process, leaving without any legal responsibility to the resin supplier, once hte bottle is opened…
We supply cost effective “safe” 3D resins but if you want to fully comply with FDA and ISO you will need to get the Certification yourselves, specially now with the incoming changes of FDA and ISO related to the manufacturing of medical devices. We can support and consult you with the design of the work flow to ensure fully compliance for the future more and more deterrent regulations

Greetings
Dr. Juan Segurola
www.3Dresyns.com

------ Original Message ------
From: REDACTED
To: info@3dresyns.com
Sent: 13/02/2019 08:31:51
Subject: Dental resins

Dear sirs

I am tasked by my employer to try to source alternative dental materials for use with our Form2 printers. We have a Form2 printing cell made up of REDACTED printers which is currently using approximately REDACTED of material per month. We currently use the Formlabs resins, but would be interested in lower cost alternatives.

In the first instance I have contacted you via my personal email in order to maintain company confidentiality, dependent on your company responses that will change to my company email address.

My questions at this stage are do you have a surgical splint and surgical aligner material that is biocompatible to ClassII(a) and do you have approvals for that in place with the FDA?

I cannot see any reference on your website to any actual ISO accreditation for your company, please confirm that you are ISO accredited, and please provide a copy of your current certificate.

I could see the following, but no proof to support the claim: “Our Dental 3Dresyns OD comply with the Quality requirements for Class I, IIa & IIb of ISO13485:2016 for the manufacturing of orthodontic and dental medical devices.”

Regards

REDACTED

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I am not a dentist or medical professional, but I have previously worked for a dental device manufacturer for 4 years (the number 1 worldwide in its field). What I have gathered during that time from people close to the end user and other people in contact with the legislative point of view, is that is is insanely easy to sell stuff to dentistry professionals, WAY easier that it would be to sell to other medical fields. I don’t why that is, but the loophole you are exposing is apparently common knowledge and manufacturers use it to “certify” stuff without taking much risks and professionals use the “certified” stuff because they seem to think to have plausible deniability in regards to possible issues due to the fact that the manufacturer of the stuff they used “certified it”… hell, they very well might be right.

Thanks John, it’s an interesting point. My own thoughts are that it’s not wise for us to buy any resins from 3Dresyns. Their email made it clear that they have no quality management system (that is accredited) in place. From our point of view we could not be certain that the quality (or even the composition) of any materials bought from them was the same from order to order.
The cost of properly testing of each batch would far outweigh any cost saving we might make against buying Formlabs materials, that’s without even considering the hassle of having to use a third party cartridge if we still want the full functionality of the printer.
Our liability insurance states we have to follow ALL legislative AND all official directives and official FDA non binding recommendations in place relating to an application or process. That means we have to respect and adhere to the directive issued by the FDA on 5th December 2017 in order to have the protection of our liability insurance.
(See page 15/16 of this - https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf)

  1. “…• if the material is a polymer or monomer mixture: composition, purity, water content, molecular formula, chemical structure, molecular weight, molecular weight distribution, glass transition temperatures, melting and crystallization point temperatures, purity information (e.g., purity of polymer/monomer and identification and quantity of relevant impurities, both inorganic and organic, as applicable)…”

I guess it makes sense for the insurers to take that line ( - follow all official guidelines and directives). We as a company are not prepared to take a chance just to save a few bucks. The resin from 3Dresyns might be great on week 1, but as we have to take all the liability once the bottle is opened and they have no accredited quality management system in place then we simply will not know that there materials will be controlled, consistent in quality, free of cross contamination from other resins they might make, or even if the raw materials they use to make their resins will be in date (the raw materials suppliers use by date) or the same from batch to batch.
So from our point of view we could not justify the potential risk of buying resins from them – even if we got them certified for ourselves (and at a lot of expense). The cost of that alone would buy a lot of resin that was free of any hassle or extra work for us…

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