BioMed Clear Resin is USP Class VI certified and manufactured in a Formlabs FDA-registered, ISO 13485 and EU MDR certified facility in Ohio. It is also supported by an FDA Device Master File. Formlabs has tested biocompatibility for common use cases to help instill confidence in potential users.

The material is designed for applications requiring long-term skin contact (greater than 30 days), breathing gas pathways, and mucosal membrane contact (greater than 30 hours), as well as short-term contact with bone, tissue, and dentin (less than 24 hours). It is not intended for permanent implantable use.

It is the manufacturer's responsibility, along with respective customers and end-users, to determine the biocompatibility and performance of all printed parts for their specific application and intended use. Formlabs provides testing data and supporting documentation to help instill confidence, but does not define intended uses for BioMed Resins the way it does for Dental Resins.

BioMed Clear Resin is compatible with Form 4B, Form 4BL, Form 3B, Form 3BL, and Form 2. It uses SLA print technology with a minimum layer thickness of 50 microns.

You will need a compatible resin tank and build platform for your printer. For the Form 4B, that means a Form 4 Resin Tank and Form 4 Build Platform (or Flex Build Platform). For large-format printing on the Form 4BL, a Form 4L Resin Tank and matching build platform are required. Mixers are also available to keep resin properly agitated during printing.

BioMed Clear Resin is well suited for end-use medical devices, models for visualization and implant sizing, biocompatible prototypes, molds, jigs and fixtures, and gas pathway connectors, adapters, and devices. Its transparency is particularly valuable for applications where visibility through a part is important.

BioMed Clear Resin is manufactured within a rigorous Quality Management System inside a certified ISO Class 8 clean room, making it appropriate for biocompatible medical applications. Standard clear resins are intended for general prototyping and do not carry the regulatory documentation, certifications, or biocompatibility testing that BioMed Clear Resin provides.

Parts must first be washed to remove excess resin using either a Formlabs-validated wash unit or an ultrasonic wash unit. Post-curing is then required to achieve the safety standards set by regulatory agencies. Full details are available in the BioMed Clear Manufacturing Guide.

The foundational post-processing step is an alcohol wash to remove excess resin from part surfaces. BioMed Clear Resin may be washed using either a Formlabs-validated wash unit or an ultrasonic wash unit. Detailed settings and instructions are available in the BioMed Clear Manufacturing Guide. Formlabs Form Wash or Form Wash L units are designed to integrate with this workflow.

Yes. For biocompatible materials, post-curing is necessary to achieve the safety standards determined by regulatory agencies. Specific curing settings and procedures are outlined in the material's Manufacturing Guide. Form Cure or Form Cure L units from Formlabs support this step.

Yes. Parts printed with BioMed Clear Resin are compatible with common sterilization methods. Formlabs has conducted sterilization compatibility testing for common use cases. Refer to the Manufacturing Guide for specific guidance on sterilization protocols.

The Technical Data Sheet, Safety Data Sheet, and Certificate of Analysis are all available through the Formlabs Data Sheets page. You can also view the ISO 13485 Certificate of Registration and request a sample part.

Pricing depends on printer series, volume, and order quantity. Bulk order discounts are available and scale based on total volume ordered. For current pricing or to discuss large-volume orders, contact Formlabs Sales.