Safety and Effectiveness Report on DuPont's Polymer Devices

Topics: Polystyrene, Styrene, Polymer Pages: 4 (918 words) Published: May 18, 2012

Our device’s Elvax® 150w and Total HIPS 4440 polymers provide a safe and effective product.


Our oral device is made of two polymers, Elvax® 150w and Total HIPS 4440, used for a variety of purposes for decades. Since developing the first synthetic fiber--nylon--from research on large molecules called polymers, DuPont has remained a leader the field. In addition to Elvax®, DuPont makes high impact polystyrene (HIPS), which is also produced by other manufacturers.

ELVAX® 150W:

Manufactured by DuPont, Elvax® is a copolymer of ethylene and vinyl acetate (EVA). It is flexible, resilient, tough, and resistant to ozone or environmental stress cracking. Elvax® can be used alone or as an additive to improve other resins or elastomers. With no plasticizer to migrate and minimal odor, Elvax® has advantages over other natural or synthetic rubbers. Its flexibility spans a broad temperature range, and Elvax® recovers rapidly under repeated instantaneous load.

As a blending resin, Elvax® improves flexibility, resilience and toughness, easily compounding with polyethylene, polypropylene, ABS, thermoplastic, nitrile, natural and compounded rubbers, and elastomers. DuPont notes the “broad compatibility of Elvax® resins with other resins.”[1]

U.S. Food and Drug Administration (FDA) regulations allow using Elvax® in contact with food.[2] As a non-biodegradable, non-inflammatory sustained-release polymer, Elvax® has been used as a sustained-release delivery medium for drugs in human implants.[3] Elvax® resins have also been used safely in the local delivery of substances through sustained-release human dental implants.[4] TOTAL HIPS 4440:

Polystyrene is a resin produced by polymerizing styrol, a thermoplastic resin used in dentures.[5] It is one of the most widely used plastics, whose use is said to reach billions of kilograms a year.[6] High-impact polystyrene (Total HIPS...
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