Search Results

Renamel Microhybrid

• · Anterior restorations (Class III and IV)
• · Deep Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• · Restorations in the posterior region (Class I and II)
• · Veneering of discolored teeth
• · Closing of diastemas by vestibular veneering
• · Repair of composite and ceramic veneers

Renamel Flowable Microhybrid

• · Class V restorations
• · Sealing margins
• · Repairing pitted areas in hybrid restorations
• · Small occlusal and lingual repairs
• · In deep Class V restorations to block out shine through prior to overlay with Renamel Microfill or Renamel Microhybrid

Not Found

This document is an FDA 510(k) clearance letter for dental restorative materials (Renamel® Microhybrid and Renamel® Flowable Microhybrid). It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter confirms that the devices are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) from this document.

Ask a specific question about this device