Search Results

MAGNABOND SE

• Bonding agent for direct restorations of all classes of cavities using light-curing composite or compomer filling materials
• Bonding agent for core build-ups that are made with light-curing composites

MAGNABOND UNIVERSAL

• Bonding agent for direct restorations of all classes of cavities using light-curing composite or compomer filling materials
• Bonding agent for core build-ups that are made of light-curing composites
• Bonding agent for intraoral repair of composite or compomers restorations, porcelain fused to metal (PFM), ceramic veneers and all-ceramic restorations without an additional primer
• Sealing of cavities prior to amalgam restorations
• Sealing of cavities and core preparations prior to the temporary luting of indirect restorations
• Treatment of hypersensitive teeth
• Protective varnish for glass ionomer cement restorations

COMBINED WITH MAGNABOND UNIVERSAL DCA:

• Bonding agent for direct restorations of all classes of cavities using self or dual curing composites and core build-ups
• Bonding agent for indirect restorations using self or dual curing luting composites/cements
• Luting of root posts using self or dual curing luting composites/cements

Not Found

N/A

Ask a specific question about this device

• Temporary crowns and bridges

• Temporary inlays and onlays

Not Found

This document is a 510(k) clearance letter for a dental device, "BRIGHT TEMPORARY C&B," and specifies its indications for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot provide the requested information based on the given text. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on the results of a specific performance study against defined acceptance criteria.

Ask a specific question about this device