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Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications. [1] In the United States, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body. It does not regulate materials other than certain dental materials.
Due to their inert nature, medical-grade Silastic-brand silicone elastomers are important materials in numerous medical and pharmaceutical devices including catheters, pacemaker leads, tubing, wound dressings, silos for abdominal wall defects, [2] and nasolacrimal duct obstruction. [3]
Silicone is used in microfluidics, seals, gaskets, shrouds, and other applications requiring high biocompatibility. Additionally, the gel form is used in bandages and dressings, breast implants, testicle implants, pectoral implants, contact lenses, and a variety of other medical uses.
Polyvinyl siloxane (PVS), also called poly-vinyl siloxane, vinyl polysiloxane (VPS), or vinylpolysiloxane, is an addition-reaction silicone elastomer (an addition silicone). It is a viscous liquid that cures (solidifies) quickly into a rubber-like solid, taking the shape of whatever surface it was lying against while curing.
A variety of fillers can be used in silicone rubber, although most are non-reinforcing and lower the tensile strength. Silicone rubber is available in a range of hardness levels, expressed as Shore A or IRHD between 10 and 100, the higher number being the harder compound. It is also available in virtually any colour, and can be colour matched.
They are widely used for luting dental restoration whereby the thickness allows penetration of light for partial curing only. On the other hand, the chemically-cured component is key in ensuring complete polymerisation and hence full strength acquisition. [16] Discolouration may occur due to the presence of aromatic amine. [17]
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Dow Corning was formally established in 1943 as a joint venture between the American conglomerates Dow Chemical and Corning Glass to explore the potential of silicone and was a manufacturer of products for use by the U.S. military in World War II. The company began operating its first plant, in Midland, MI, in 1945.
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