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Indicated for the injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures.

The CCS computer controlled syringe is a programmable electronic device that allows the injection of local anesthetics commercially available and packaged in cartridge form. The device consists of a programmable control unit, and a handpiece with switches that actuate the function of the device as programmed. Single use, replacement cartridge holders are available to facilitate universal injection technique.

This looks like a submission record to the FDA for a 510(k) premarket notification for a medical device. Based on the provided text, there is no information about specific acceptance criteria, a study proving device performance against those criteria, or the details typically associated with clinical performance studies (sample sizes, ground truth establishment, expert qualifications, etc.).

The document {0} states "Performance data is presented in the 510(k) submission," but this specific summary does not contain that data or the acceptance criteria. The subsequent pages {1}, {2}, and {3} are an FDA response letter confirming substantial equivalence to a predicate device and the "Indications For Use" statement.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets those criteria, as these details are not present in the provided text.

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