Medical 3D Parts › Safety
What we won't make, and why
Makers here print models and accessories with no medical purpose. Everything that goes in or on the body, is made for a patient, or is used to diagnose or treat goes to a dentist, doctor or registered lab.
Last reviewed 14 October 2026. Rules differ by country and change: check the official source.
Our position
medical3dparts.com is run by The Spool List, a marketplace where independent makers quote on 3D printing jobs. Makers are hobbyists and small workshops. They are not registered medical device manufacturers or dental laboratories, and The Spool List is not one either.
Whether something is a medical device depends on what it is made and sold for (US FD&C Act §201(h); EU Regulation 2017/745 Art. 2; UK MHRA guidance) [1][2][3]. So we only accept jobs for models and accessories with no medical purpose: anatomy and dental models for teaching and display, typodonts and practice teeth for students, models that help explain a procedure in general terms, prototypes not for patient use, and organisers and holders that never touch a patient.
We do not accept jobs for dentures, crowns, bridges, veneers, aligners, retainers, night or mouth guards, implants, surgical instruments or guides, prosthetics, orthotics, splints, replacement parts for medical equipment, anything sterile, anything that goes in the mouth or body, or models made from a patient's scans for diagnosis or treatment planning. In the US, UK and EU these are regulated, and dental appliances are made by registered labs to a dentist's prescription.
A printed part is not 'biocompatible' because of the resin used: biocompatibility depends on a validated process, and resin makers say so themselves [5]. Printed plastics like PLA can deform in an autoclave [6]. Do not put any part bought here in your mouth or body or use it in a clinical procedure.
This site is general information, not medical, dental or legal advice. If you need treatment, talk to a qualified professional. Payment is held by The Spool List until you confirm delivery.
Our reading of the definitions: a model made and sold only for teaching, display or practice, with no medical purpose claimed, is not sold as a medical device. No regulator we found says this in those words, so treat it as our reading, not a regulator's statement.
What makers here print
Anatomy teaching and display models
Skulls, skeletons, hearts, organs and bones from generic or open educational files, labelled for education and display.
Dental teaching models
Typodonts, practice teeth, enlarged teeth and jaw models for students and educators.
Communication and display models
Generic anatomy, giant teeth and jaw demonstrations that explain a procedure in general terms. Never made from a particular patient.
Training and simulation models
Practice aids for skills training that never touch a patient and are never used to diagnose.
Lab and clinic accessories
Desk organisers, model trays, label and sign holders, cable clips, tablet stands, and racks for non-sterile use. They stay outside the cleaning and sterilisation cycle.
Prototypes and props
Form and fit prototypes and trade-show models marked 'prototype, not for patient use', and non-functional props for film, theatre and training scenarios.
What makers here never print
Dental appliances
Dentures and denture teeth, crowns, bridges, veneers, temporaries, aligners, retainers, brackets, night and mouth guards, snoring appliances and whitening trays. See your dentist.
Anything in or on the body
Anything worn in the mouth, placed in or on the body, or fitted to a patient. Body contact needs a validated, tested process that a maker cannot provide.
Implants, instruments and guides
Implants of any kind, surgical instruments, and surgical, drilling or cutting guides. The FDA lists implants, instruments and dental restorations among 3D printed medical devices [4].
Models from a patient's scans
Patient-specific models from CT or MRI for diagnosis or surgical or treatment planning. Stratasys, a printer maker, summarises FDA's position: models marketed for diagnostic use must be made with FDA-cleared software [7].
Prosthetics, orthotics, splints and casts
Anything fitted clinically. See your doctor, prosthetist or orthotist.
Parts for medical equipment
Replacement parts for ventilators, pumps, monitors, hospital beds or the structural and brake parts of wheelchairs. Changing a device's components can make someone its manufacturer under FDA rules [8].
Anything sterile or single-use clinical
Nothing printed here is sold as sterile or sterilisable, or for use in a clinical procedure.
Anything with a medical claim
Jobs or listings that say a part treats, relieves, diagnoses or is 'for patients with' a condition. The claim itself can make a product a medical device, and a disclaimer does not cancel a claim made elsewhere [3].
Where we draw the line on borderline items
- Organisers for instruments are desk storage only, never cassettes or trays that go through cleaning or sterilisation: EU law treats products made for cleaning or sterilising devices as devices [2].
- Everyday grip and reach helpers are not offered on this site, because a medical site implies a medical purpose.
- Working models a dental lab uses to make a patient's appliance are part of that lab's own work, not a job for a maker here.
Looking for 3D printed teeth? Read the dental page →
Sources
- FDA: How to determine if your product is a medical device (FD&C Act §201(h))
- Regulation (EU) 2017/745 on medical devices, Article 2 (EUR-Lex)
- MHRA: Guidance on legislation, Borderlines with medical devices (PDF, V1.1, May 2016)
- FDA: 3D printing of medical devices
- Formlabs: BioMed Clear Resin product page
- Neijhoft et al., Sterilization of PLA after fused filament fabrication 3D printing, Polymers 2023;15(2):369
- Stratasys: FDA-cleared 3D printing solutions
- FDA guidance: Remanufacturing of medical devices (May 2024)
- MHRA: Borderlines with medical devices and other products in Great Britain (updated 29 June 2026)