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PANAVIA F is indicated for the following applications:

• Cementation of metal crowns and bridges, inlays and onlays. 1)
• Cementation of porcelain crowns, inlays, onlays and veneers. 2)
• Cementation of composite resin crowns, inlays and onlays 3)
• Cementation of adhesion bridges and splints 4)
• Cementation of metal cores and prefabrication posts 5)
• 6. Bonded amalgam restorations

PANAVIA F is classified into dental cement, CFR 21 Section 872.3275, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for cementation of dental devices such as crown and bridges.

This 510(k) summary is for a change of ownership and address for an already cleared device, PANAVIA F. It is not a submission for a new device requiring performance testing against acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this specific 510(k) submission.

The document states: "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes."

The FDA's response confirms that they have reviewed the notification and determined the device is "substantially equivalent" to legally marketed predicate devices, which is the standard for 510(k) clearances, especially for administrative changes like this.

In summary, there is no performance study or acceptance criteria analysis presented in these documents because the submission is for an administrative change, not a new device or significant modification requiring new performance data.

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