Ketac Cem U

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K002793 ↗

FDA Product Code

EMA

Device Class

Class II

Regulation

21 CFR Part 872.3275

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Espe Dental AG →

• What is Ketac Cem U primarily used for in dental procedures, and how does it differ from other luting cements?

  Ketac Cem U is a radiopaque glass ionomer luting cement designed specifically for chemical bonding with dentin and enamel. This allows it to provide durable fixation for restorative materials like crowns, inlays, or onlays, ensuring long-term stability. Unlike some other luting cements, its glass ionomer composition releases fluoride, which may help remineralize tooth enamel and reduce decay risk over time. It is supplied as a powder-liquid system, making it easy to mix and apply directly in clinical settings.

• Is Ketac Cem U intended for single-use or can it be reused after mixing?

  Ketac Cem U is explicitly supplied as a single-use product. The powder-liquid system is formulated for one-time clinical application to ensure sterility and performance consistency. Reusing mixed cement could compromise its integrity, bonding strength, or sterility, which is why it is not recommended.

• What regulatory pathway was followed for FDA clearance of Ketac Cem U, and what does this mean for its classification?

  Ketac Cem U received FDA clearance under the Special 510(k) Review pathway, with a clearance number of K002793. This classification places it as a Class II device, meaning it is subject to special controls to ensure its safety and effectiveness for use as a dental luting cement. The Special 510(k) designation indicates that the FDA determined it to be substantially equivalent to a predicate device already on the market.

• How is Ketac Cem U packaged and stored, and are there any special handling instructions?

  While the exact packaging details aren’t specified, Ketac Cem U is supplied as a powder-liquid system, which is typical for glass ionomer cements. It should be stored in a dry, cool environment (as with most dental materials) to maintain its stability. The powder and liquid components should be kept separate until use to prevent premature setting. Always follow manufacturer guidelines for mixing ratios and working time to ensure optimal performance.