Medical 3D Printing

Patient-specific.
ISO 10993 materials.
Clinically ready.

Medical 3D printing for patient-specific applications: surgical guides, anatomical models, dental hardware, custom orthotics. ISO 10993 biocompatible materials, USP Class VI where applicable, ISO 13485-compatible documentation workflow.

Medical 3DP Quote Medical CNC

ISO 10993 Patient specific Ti Gr.23 implants Surgical guides

01 · Medical 3D materials

Medical-grade 3D printing materials.

Medical applications require specific certified materials. Here are the medical-grade 3D printing options available.

Medical PA12

ISO 10993 · MJF/SLS

Biocompatible PA12 nylon for external medical devices, orthotics, custom patient hardware.

Medical resins

USP Class VI · SLA

Biocompatible SLA resins: surgical guides, dental models, orthodontic appliances.

Ti-6Al-4V Gr.23

ASTM F2924 · DMLS

ELI titanium implants via DMLS. Spine cages, cranial plates, orthopedic implants. Post-processed to finished implant.

PEEK medical

Invibio grade

Implantable medical PEEK via FDM. Limited to specific licensed applications.

CoCr dental

F75 · DMLS

Cobalt-chromium for dental crowns and bridges. Standard material for dental 3D printing.

Ti Gr.5 medical

ASTM F136 · DMLS

Standard titanium for dental implants, non-permanent orthopedic. Less stringent than Gr.23.

316L Medical

SLM

316L stainless for non-permanent medical hardware, dental instruments.

Surgical guide resin

USP VI · clear

Clear biocompatible SLA resin specifically for surgical guides — autoclavable.

02 · Medical applications

Medical 3D printing applications.

Surgical guides

Patient-specific surgical guides from CT/MRI imaging data — accurate implant placement

Anatomical models

3D printed models from patient imaging for surgical planning, physician training

Dental crowns & bridges

CoCr and ceramic dental restorations via 3D printing

Orthodontic appliances

Clear aligners, retainers, orthodontic treatment devices

Cranial implants

Patient-specific titanium cranial plates for reconstruction

Spine cages

3D printed spine cage implants with porosity for osseointegration

Custom orthotics

Patient-specific foot orthotics, prosthetic socket liners

Bone scaffolds

Research bone tissue scaffolds with controlled porosity

Device prototypes

Medical device development prototypes in biocompatible materials

FAQ

Medical 3DP questions.

ISO 10993: international standard for biocompatibility testing of medical devices. Required for FDA submissions, CE marking. Comprehensive testing (cytotoxicity, sensitization, irritation, implantation). USP Class VI: United States Pharmacopeia classification. Older standard, still referenced but ISO 10993 is becoming universal. Both certify biocompatibility for specific uses. Specify which certification your application requires.

For patient-specific devices (surgical guides, anatomical models): typically Class I device, FDA 510(k) exempt. For implantable 3D printed devices (cranial plates, spine cages): Class II or III, 510(k) or PMA required. Manufacturing must comply with FDA 21 CFR Part 820 QSR, ISO 13485. We provide components under customer's QSR/ISO 13485 system — not manufacturers of complete medical devices ourselves. Our documentation supports customer QSR.

Typical workflow: (1) Customer provides CT or MRI imaging data. (2) Imaging segmented and processed into 3D model of anatomy. (3) Surgeon reviews and approves model/guide design. (4) 3D printing in appropriate biocompatible material. (5) Post-processing (support removal, sterilization). (6) Packaging with unique patient identifier. We support steps 4-6, typically working with customer or partner who handles steps 1-3.

Medical 3D printed parts must survive sterilization: autoclave (121 °C, 15 psi steam), gamma radiation, ethylene oxide (EtO). Compatibility: Ti, PEEK, 316L — all methods. Medical SLA resin: limited autoclave cycles, gamma OK. Medical PA12: gamma and EtO preferred over autoclave. Specify sterilization method — we select appropriate material and process.

Surgical guides from imaging: 5-7 days typical. Dental crowns: 1-3 days (standard production). Patient-specific implants: 2-4 weeks including design approval and regulatory process. For emergency cases (surgical rescheduling), rush turnaround possible. Documentation packages add 1-3 days.

Medical 3D printing documentation: material certification (lot number, biocompatibility certification), process record (machine, operator, parameters), post-processing record, quality verification, patient identifier (if patient-specific). We provide documentation package compatible with customer's ISO 13485 QMS. For traceability required long-term retention, records archived for specified period.