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These products have the same intended use, to act as a physical barrier, augmenting existing infection control techniques and make clean-up and disinfection easier. These are the same as those of the predicate devices. These products also have the same intended uses as similar products currently cleared for marketing by the 510(k) process.

These disposable plastic shields are for use with various small hand-held dental instruments such as handpieces, ultrasonic scalers, jet polishers, contra angle handpieces, and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, headpieces, accessory trays, x-ray heads, and others. They are manufactured from clear polyethylene and formed to provide excellent tactile control combined with simple coverage and removal from the instrument. These shields act as as physical barriers which augment existing infection control techniques and simplify existing clean-up and disinfection methods. They do not obviate, in any way, existing good dental practices such as sterilizing handpieces, hand instruments, etc between each patient. The various products are designed to slip over the ends of the respective devices, allowing for attachment and/or protrusion of those parts of the devices that are inserted into the patient's mouth (instruments), or otherwise contact the patient (chair covers). The products will be sold non-sterile, prepackaged, and are disposable, single use only.