Biocompatible/non toxic 3D resins

luispa

Registered
Hi,
This is my first post here. I’m starting a new business which consists of printing saxophone mouthpieces using 3D resins. Here a few considerations about the pieces use:
  • The mouthpiece is intended to be used inside the mouth.
  • The usual exposition time could be from 1hr to 8hrs (not the most usual) for a day, for less than 1h without interruptions.
  • While the mouthpiece is in use it will not be inside the mouth for more than 10 minutes without interruptions, getting the piece outside the mouth.
  • As far as I know this could require type I biocompatibility, please correct me if I’m wrong.
  • The most popular material used for saxophone mouthpieces is hard rubber despite it’s known for being not very safe (can release sulfuric acid).
  • Other common materials are brass and then gold/silver plated. The makers don’t release information about their alloys so when the plating rip off the mouth is in contact with an unknown material. Other materials are stainless steel (surgical grade or no) which seems to be safer than brass. Other plastics used for producing saxophone mouthpieces are Delrin (FDA approved material), PC (Bisphenol A???), PS, PMMA, PLA, ABS, etc.
  • AFAIK, there's no regulation about materials used in these products.
You can easily realize this is a market which is not too afraid of the mouthpiece related health risks.
I fully understand that biocompatibility is not only related to the raw material, it also depends on the printing process (including printing, cleaning and postcuring) and the printer used and its condition.
I want to use a resin which allows me to produce safe products if I use the right process. Here my questions:
  • Which resins would meet my requirements in a cost effective way? I do prefer clear resins because that allows a best post curing process.
  • Are BIO/PLA/Plant based resins which are “certified” EN71-3 suitable for this pieces?

I don't know if this is the right forum for asking these questions, if not please feel free to move this post to the right forum/subforum.

Thank you very much in advance.
 

luispa

Registered
Try Dental Product Resins.
Thank you for your reply. That seems to be the safest choice but I don't know if the pieces I'll produce require that level of biocompatibility (higher level of biocompatibility, higher is the price), given the fact the saxophone mouthpieces only require to meet the requirements of "Surface devices" (ISO 10993-1, Table 1) it seems to be unnecessary to pay for a resin designed for an "Implant Device" which can be in contact with bones and blood.

I'd like to know if an "EN71-3" certified resin will enough for these pieces or if I`ll need an ISO 10993 certified resin. I can't find an answer to that question.
 
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