Ceramco High Fusing Foil Solder

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833434 ↗

FDA Product Code

EJS

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What is the Ceramco High Fusing Foil Solder used for in dental procedures?

  The Ceramco High Fusing Foil Solder is specifically designed for joining ceramic and metal components in dental restorations. It creates strong, durable bonds between these materials, ensuring stability in crowns, bridges, or other restorative work where ceramic and metal interfaces require precise soldering. Its noble metal alloy composition helps maintain compatibility with both materials, reducing the risk of weak joints or failure over time.

• Is the Ceramco High Fusing Foil Solder intended for single-use or reusable applications?

  This device is supplied as a single-use dental material. Using it only once helps maintain sterility and reliability, as reuse could compromise the integrity of the solder or introduce contamination. Single-use also aligns with dental best practices for infection control and ensures consistent performance for each procedure.

• How should the Ceramco High Fusing Foil Solder be stored to preserve sterility?

  The foil solder should be stored in its original, sealed packaging to protect it from moisture, dust, or contamination. Keep it in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the material remains sterile and ready for use when needed, maintaining its intended performance for precise dental soldering.

• What regulatory approval does the Ceramco High Fusing Foil Solder hold in the U.S.?

  The Ceramco High Fusing Foil Solder is cleared by the FDA under a 510(k) submission (K833434) as a Class II device under product code EJS. This clearance confirms it meets U.S. regulatory standards for safety and effectiveness as an alloy of other noble metals for dental soldering applications. The device has been authorized for use since 1983.

• Are there different sizes or models of the Ceramco High Fusing Foil Solder available?

  The provided data does not specify distinct sizes or models beyond the general product name. However, the device is listed under multiple registration numbers, which may correspond to variations in packaging or batch sizes. For exact specifications, refer to the manufacturer’s documentation or consult Johnson & Johnson Professionals for details on available formats or foil thicknesses.