Biocompatibility Support

We believe in the safety and efficacy of its silicone products for healthcare and medical applications. Many of our Silbione® products have been tested to meet US FDA, USP Class VI and ISO 10993 requirements. Select products are supported by a Master File (MAF) on file with the FDA Center for Devices and Radiological Health (CDRH).

Our on-staff PhD Toxicologist is available to support customers with biocompatibility needs, including product attestations, toxicological summaries and 510K filings, IDE, and PMA submissions to the FDA.

See the Technical Data Sheets (TDS) for testing data or click on a product family below:

Silbione® Resources: