Search Results

Vita PM7 pressable ceramic is to be used for the fabrication of

• Single and multi-surface inlays O
• Onlays o
• Veneers O
• Partial crowns ্
• Anterior crowns 0
• Premolar crowns o

Also for oxide-ceramic crown and bridge substructures to be veneered with conventional porcelain.

For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Vita PM7 Pressable Ceramic." It primarily addresses the regulatory approval of the device based on substantial equivalence to a predicate device.

This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific study-related details requested in the prompt.

The letter confirms that the device is classified as Class II and can be marketed subject to general controls. It also includes the "Indications for Use" for the device, which specify the types of dental restorations it can be used for (e.g., inlays, onlays, veneers, crowns).

Therefore, I cannot provide the requested information based on the given input.

Ask a specific question about this device