Frequently Asked Questions
How do I know if a material is biocompatible?
Biocompatibility is assessed in the broader context of such factors as the intended use – safe to touch or on body components - location of a device in or on a patient, how manufacturing processes‐‐‐including 3D printing and post‐processing‐‐‐have impacted the chemistry of a material, and how degradation products of that initial material can affect the patient. For our materials, you will find the test results and biocompatibility features in our Technical Data Sheet (TDS).What does Class I, II, and III medical devices mean?
According to the FDA website, medical devices are categorized into “one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. The classes are designated according to the level of control necessary to ensure the safety and effectiveness of the device.” Class I devices pose the lowest risk, and Class III devices present the greatest risk.Has your 3D printing quality management system been verified and/or validated?
Henkel’s Concord laboratory and Dixon production facilities in California, USA, which are dedicated to developing and manufacturing resins for 3D printing, have achieved ISO 13485:2016 certification.Do you assist in Class III medical devices/solutions?
Class III medical devices are not handled by Henkel’s additive manufacturing solutions for Healthcare.Where can I find the recommended post processing steps for medical resins?
Please refer to our Printer and Post processing settings to get the detailed workflow.What range of medical devices or healthcare applications does your material work for?
Henkel materials support for Class I and Class II medical devices and healthcare equipment/components that require biocompatibility or safe to touch.- Prototypes, Development, and non‐patient interaction tools
- Anatomic models for education
- Wearables and Hearing Aids
- External prosthetics and assistive devices
- Dental applications by our partners Keystone Industries
- Surgical planning (anatomic models, surgical guides)
