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:
Cleaning Fluid Bio for washing and cleaning 3D prints
Cure-Tester & Purification kit for cleansing 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