Medical 3D Parts › Guides
How to brief, print and label teaching, display and prototype models, and where the line is. Each guide opens with the short answer; every rule links to its source.
Makers with 3D printers can print skulls, skeletons, hearts, organs and bones for classrooms, study and display, from generic or open educational anatomy files. Brief the model as a teaching or display model, check the file's licence, and label it as an education model. Models made from a patient's scans for diagnosis or treatment planning are a different, regulated thing and are not printed here.
A typodont is a model of the mouth that dental and hygienist students practise on. Makers with resin printers can print typodont parts, practice teeth, enlarged teeth and jaw models for teaching and display. They do not print anything for a patient's mouth, or working models for a lab's patient cases.
Resin printing suits small models where surface detail matters, such as teeth and small bones. FDM suits larger and sturdier models that are handled a lot. Ask the maker which printer and material they plan to use and why. No printing material makes a model safe for the mouth or body: that depends on a validated process, not the material.
Put a short line on every anatomy or dental model: 'Education and display model. Not a medical device. Not for diagnosis, treatment planning or use in the body.' Keep the brief, the listing and any description to teaching, display or prototyping, because regulators look at all of them, and a disclaimer does not cancel a medical claim made elsewhere.
Makers can print organisers and holders for labs and clinics that never touch a patient and stay outside the cleaning and sterilisation cycle: desk organisers, model trays, label and sign holders, cable clips, tablet stands and racks for non-sterile use. Anything made to clean or sterilise devices, or that holds instruments through a sterilisation cycle, is out.
A maker can print form and fit prototypes, housings and trade-show models for a device company, marked 'Prototype. Not for patient use.' They are for looking at, handling and testing fit, never for use on a person. Design validation, testing and regulatory work for the finished device stay with the company that will make it.
Say what the model is for (teaching, display, practice or a prototype), attach the file or link its source and licence, and give the size, material preference, colours, labels, quantity, deadline and budget. Never include a patient's name or scans. A clear brief gets comparable quotes.
It depends on what the model is made and sold for. The US, EU and UK definitions turn on intended purpose and claims. Our reading is that a model made and sold only for teaching or display, with no medical purpose claimed, is not sold as a medical device. A model used to diagnose or plan a patient's treatment is regulated. This is our reading, not legal advice, and we found no regulator that states it in those words.
Biocompatibility is a property of a validated process (resin, printer, settings, washing, curing and sterilising), not of a bottle of resin. Even resin makers say determining biocompatibility is the device manufacturer's job. A maker with a 'biocompatible' resin cannot make a part safe for the mouth or body, and nothing printed through this site is sold for that.
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