General Info
Ketron® LSG PEEK-CLASSIX™ (white) are Life Science Grade stock shapes made from Invibio PEEK-CLASSIX™ resin. Both resin and stock shape are pre-assessed for biocompatibility for up to 30 days contact with body and tissue according to USP VI and ISO 10993.
With a unique combination of mechanical properties, chemical resistance, sterilization resistance, and white color, Ketron® LSG PEEK-CLASSIX™ (white) components can be used in a variety of applications in the medical and dental industries involving body contact for a duration up to 30 days. Used primarily as temporary dental abutments, these shapes are also great candidates for applications such as air and drug delivery systems and blood management components.
- Pre-assessed on both resin and stock shapes for up to 30 days contact with body or tissue according to USP Class VI and ISO 10993
- PEEK-CLASSIX™ base material provides enhanced mechanical properties and chemical resistance, allowing longer term body or tissue contact than other LSG grades
- Excellent sterilization resistance via steam, dry heat, EtO, plasma, and gamma- & X-ray irradiation
- White color for dental applications
Application & Testing Information
Pre-assessment Testing
Ketron® LSG PEEK-CLASSIX™ (white) carries the following compliances:
- ISO 10993-5 and USP <87> Cytotoxicity
- ISO 10993-10 Sensitization
- ISO 10993-10 and USP <88> Intracutaneous Reactivity
- ISO 10993-11 and USP <88> Acute Systemic Toxicity
- USP <88> Implantation Test
- USP Class VI (conclusion of three of the above ISO 10993 and USP <88> tests)
- ISO 10993-4 Human Blood Compatibility
- USP <661> Physiochemical Testing
- Animal Free Origin
Please note: In some cases, different color variations of a material grade carry different approvals. Please see product documentation for details.
Intended Use
Ketron® LSG PEEK-CLASSIX™ (white) is only intended for applications in which the duration of contact with human body tissue is limited to less than 30 days.
Furthermore, LSG materials are not intended for use in the manufacture of medical devices that will be permanently implanted in the body, nor are they intended for use in life-sustaining medical devices.
Click for more information on the complete line of Ketron PEEK Plastic Products
Key Properties
- Pre-assessed on both resin and stock shapes for up to 30 days contact with body or tissue according to USP Class VI and ISO 10993
- PEEK-CLASSIX base material provides enhanced mechanical properties and chemical resistance, allowing longer term body or tissue contact than other LSG grades
- Excellent sterilization resistance via steam, dry heat, EtO, plasma, and gamma- & X-ray irradiation
- White color for dental applications
Limitations
Applications
- Used primarily as temporary dental abutments, these shapes are also great candidates for applications such as air and drug delivery systems and
blood management components.
Ketron LSG PEEK-CLASSIX (white) is only intended for applications in which the duration of contact with human body tissue is limited to less than 30 days.
Furthermore, LSG materials are not intended for use in the manufacture of medical devices that will be permanently implanted in the body, nor are they intended for use in life-sustaining medical devices.
Resin Trade Names
Manufacturer Trade Names
- KETRON® CLASSIX™ LSG PEEK
Boedeker Plastics, Inc. stocks & supplies plastic sheet, rod, tube, film and custom profiles and machine parts from these shapes that are produced from plastic resin. In many cases the manufacturer of the shape has their own product trade name. If your specification calls for a specific resin grade or manufacturer trade name, we can supply a shape made from that resin to meet your specification or suggest an equal. If you require a specific resin or brand it must be specified at the time of order.
Available Sizes
Ketron LSG PEEK-CLASSIX(white) stock shapes encompass a range of standard sizes in the following geometries: Rod, Plates.
Availability of products, shapes, and colors may differ by region.
Minimums and longer lead times may apply.
