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The SONICFill 2010 is a dental delivery system intended to be used to dispense Metamorphosis, a dental restorative resin, directly into dental cavities.

The SONICFill 2010 is an air driven dental delivery system intended to dispense Metamorphosis, a dental restorative resin, directly into dental cavities. The device allows fast and easy extrusion of the composite, which is held in single-dose cartridges (tips). The tips are connected to the device via a screw thread. The device is attached to the dental unit through a coupling and a hose. It is powered via compressed air supplied by the operative unit. The device is switched on and off through the footswitch of the dental unit and the power output can be adjusted through a regulating ring located on the device. The devices can be sterilized by the steam autoclave method.

This document is a 510(k) summary for a dental delivery system, SONICfill 2010. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance data for the SONICfill 2010 device itself.

Therefore, the requested information about acceptance criteria, device performance, study details, and ground truth cannot be extracted from the provided text for the SONICfill 2010 device. The document primarily identifies the device, its intended use, and claims substantial equivalence to another legally marketed device (Produits Dentaires Pierre Rolland, Expasyl Power Applicator (K051933)).

No studies or performance data specific to the SONICfill 2010 demonstrating it meets acceptance criteria are presented in this 510(k) summary.

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