Safety & regulatory

This page provides an overview of regulatory, quality and safety-related aspects relevant to the use of 3Dresyns® materials. It clarifies our regulatory positioning, documentation approach and compliance framework without duplicating information already available at product or application level.

Regulatory positioning

3Dresyns® develops and supplies advanced 3D printing resins for industrial, dental and medical research and development applications. Regulatory status and suitability depend on the specific material, intended use and jurisdiction.

Customers are responsible for ensuring compliance with applicable regulatory requirements for their specific application and region.

Biocompatibility considerations

For materials intended for biomedical or dental research and development, biocompatibility-related information is provided where relevant.

This may include:

• Reference to applicable standards or testing frameworks

• Material-specific biological interaction considerations

• Research-use positioning

Final qualification, certification and regulatory approval of end-use parts or devices remain the responsibility of the customer.

Quality and testing principles

3Dresyns® applies internal quality and testing procedures appropriate to the development and supply of specialty photopolymer materials.

Quality-related information may include:

• Raw material control and traceability principles

• Internal testing and validation approaches

• Performance consistency considerations

Detailed quality documentation may be provided upon request where appropriate.

Safety Data Sheets (SDS / MSDS)

Safety Data Sheets are provided upon request in accordance with applicable chemical safety regulations and internal data management policies.

This controlled access ensures:

• Correct document versioning

• Regulatory compliance

• Appropriate use of safety-related information

Requests should specify the product(s) concerned and the intended application context.

Regulatory responsibility

The use of 3Dresyns® materials in regulated environments requires appropriate validation, testing and approval by the customer or end user.

3Dresyns® does not assume responsibility for regulatory approval of final parts, devices or products manufactured using its materials.

Further information

For regulatory, safety or compliance-related questions not addressed through existing pages, customers are encouraged to contact the 3Dresyns® technical team to discuss their specific requirements.