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Clean'n'Oil is a maintenance spray for lubrication and cleaning of Turbines, Straight and Contra-Angled Handpieces, Air-Scalers and Air-Motors.

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I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Clean 'n' Oil."

This type of letter primarily indicates that the FDA has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. It does not contain information about specific performance acceptance criteria or detailed study results.

The document mentions:

• Trade/Device Name: Clean 'n' Oil
• Regulation Number: 872.4200
• Regulation Name: Dental Handpiece and Accessories
• Regulatory Class: I
• Product Code: EGS
• Indications For Use: "Clean'n'Oil is a maintenance spray for lubrication and cleaning of Turbines, Straight and Contra-Angled Handpieces, Air-Scalers and Air-Motors."

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or a more detailed 510(k) summary that includes performance testing. The current document is a regulatory approval letter based on substantial equivalence, and it does not contain the information you are looking for regarding acceptance criteria or detailed study data.

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