(72 days)
KaVo QUATTROcare is a unit intended for internal cleaning, i.e, purging of old lubricant, for the maintenance of rotating dental and surgical instruments. The KaVo QUATTROcare spray can is a component of the KaVo QUATTROcare unit and is specifically designed to fit this unit only. The lubricant spray can is unable to be used manually. NOTE: The Kallo QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.
The KaVo QUATTROcare Modified is a unit that uses an aerosol product based upon hydrocarbon propellants with a lubricant for use in the routine maintenance (cleaning and lubrication) of dental handpieces prior to sterilization. The lubricant is housed within a spray can and is a component of the unit. The KaVo QUATTROcare Modified device was modified to enhance the secure fit of the lubricant spray can to the unit through the utilization of two independent sealing systems - the screw can sealing and an additional O-ring sealing in the connector.
This looks like a 510(k) premarket notification for a dental handpiece lubricant/cleaner device. The provided text does not contain any information regarding acceptance criteria, study design, or performance metrics for the KaVo QUATTROcare Modified device. It primarily focuses on the device's description, intended use, and claim of substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory submission focused on substantial equivalence, not a performance study report.
If you have a different document that details the performance study for K071288, please provide it, and I would be happy to analyze it for the requested information.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.