Embrace WetBond Restoration and PFM Repair Kit

The Embrace WetBond Restoration and PFM Repair Kit is specifically designed for repairing and restoring porcelain-fused-to-metal (PFM) restorations and dental ceramics. It avoids traditional bonding agents like silane and instead uses a solvent-free resin system, which enhances adhesion to both ceramic and metal substrates. This makes it ideal for restoring damaged PFM crowns, bridges, or inlays without requiring additional bonding steps, simplifying the repair process for trained dental professionals.

Yes, the Embrace WetBond Restoration and PFM Repair Kit is supplied as a single-use system, meaning each kit is intended for one procedure only. This design ensures sterility and prevents cross-contamination between patients. For your practice, this means you’ll need to stock individual kits for each repair, but it also eliminates the need for sterilization or reprocessing between uses, streamlining workflow and reducing risk.

The kit follows standard dental supply protocols for storage, which typically means keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Since it’s packaged sterile, ensure the seal remains intact until use. The components are designed for direct application to prepared surfaces, so no additional preparation beyond standard dental hygiene practices is required before opening the kit.

The Embrace WetBond Restoration and PFM Repair Kit is regulated under FDA 510(k) clearance (K032953) as a Class II medical device, with a decision described as *Substantially Equivalent* to predicate devices. This means it has undergone FDA review to ensure safety and effectiveness for its intended use—repairing PFM restorations and ceramics—without requiring additional bonding agents. Your office must adhere to FDA regulations for dental materials (e.g., 872.3200) and maintain proper documentation, but no further licensing or approval is needed beyond standard dental practice compliance.

The kit is primarily designed for porcelain-fused-to-metal (PFM) restorations and dental ceramics, as stated in its description. While it includes materials compatible with metal substrates (due to its solvent-free resin system), its primary indication is for repairing damaged ceramic surfaces within PFM restorations. For metal-only restorations, traditional bonding agents or alternative repair systems may be more appropriate, as the kit’s formulation is optimized for ceramic-metal interfaces.