Rigid, Biocompatible, and Transparent for Advanced Clinical Care
BioMed Clear Resin is a USP Class VI certified material validated for applications requiring long-term skin contact (>30 days) and short-term mucosal membrane, bone, tissue, and dentin contact (<24 hours). Manufactured in an ISO 13485-certified facility, this resin is the gold standard for transparent medical components. On the Form 4B, it achieves exceptional dimensional accuracy, making it ideal for fluidic manifolds, surgical guides, and diagnostic hardware.
Key Features
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Optical Transparency: Offers excellent clarity once polished, essential for visualizing internal fluid flow or underlying anatomy during surgery.
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Comprehensive Biocompatibility: Certified USP Class VI and tested for ISO 10993 compliance, supporting long-term skin and short-term internal contact.
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Multi-Method Sterilization: Validated for compatibility with autoclave (steam), Ethylene Oxide (EtO), and Gamma radiation.
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Regulatory Support: Supported by a Device Master File (DMF) at the FDA, simplifying the regulatory path for new medical device submissions.
Ideal Applications
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Surgical Guides & Templates: Rigid, transparent guides that allow for direct visualization of the surgical site.
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Fluidic Devices & Manifolds: Transparent components for gas or liquid delivery with visible internal channels.
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Medical Device Components: Patient-contacting housings, connectors, and covers for diagnostic equipment.
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Surgical Planning Models: High-detail, transparent anatomical models to visualize internal pathologies (e.g., vascular or orthopedic).
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Bioprocessing Equipment: Custom, transparent fixtures for laboratory and pharmaceutical environments.
FAQ
How do I achieve maximum clarity?
Parts come off the printer with a frosted finish. To achieve "crystal clarity," sand the parts with fine-grit sandpaper (up to 2000-grit) and finish with a biocompatible clear coating or medical-grade polishing compound.
Is this different from Standard Clear Resin?
Yes. BioMed Clear is manufactured in a controlled environment (ISO 13485) and has passed rigorous biocompatibility and sterilization testing. Standard Clear is for general prototyping only.
Can I use this on a standard Form 4 (Non-B)?
No. BioMed Clear is officially validated for use on "B" series printers (Form 4B). These printers are designed to run the specific validated settings required to guarantee the material's certified medical properties.
