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The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures.

The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures. The control unit is equipped with a roller pump to deliver saline solution or sterile water as irrigant to the handpiece. The electric micromotor and its cord are not autoclavable; therefore, adequate covering by plastic sleeving as commonly used in dental for infection control method is necessary. The irrigation tube set used between the irrigation nozzle at the handpiece and the saline solution bottle via roller pump is supplied as an accessory item in the control unit package. It is ETO sterilized for 10 ° sterility, pyrogen-free. The control unit has risk of explosion if used in the presence of flammable anesthetics.

The provided document is a 510(k) premarket notification letter from the FDA for a dental surgical control unit (Surgic II Implant Control Unit). This type of document primarily confirms substantial equivalence to a predicate device and allows marketing. It does not contain acceptance criteria or study results as typically found in clinical trial reports or performance testing summaries.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the criteria. The document focuses on regulatory approval based on "substantial equivalence" rather than detailed performance reporting against pre-defined acceptance criteria from a specific study.

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