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Clean and Boost is an acidic, aqueous cleanser that has been designed to help remove contaminants from the surface of a tooth prior to bonding. These contaminants can be hand piece oil, tooth debris, or imaging powder (used to create digital impressions for CAD/CAM restorations).

Clean and Boost is an acidic, aqueous cleanser that has been designed to help remove contaminants from the surface of a tooth prior to bonding.

The provided text is a 510(k) premarket notification letter from the FDA for a dental product called "Clean and Boost." This document confirms the regulatory approval of the device but does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the manufacturer demonstrated substantial equivalence to a predicate device, which is a different type of submission than one requiring detailed performance studies against specific acceptance criteria. The FDA often relies on substantial equivalence for Class II devices like this resin tooth bonding agent.

Therefore, I cannot provide the requested information from the given text because it is not present.

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