Ultra-Bond Cement

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Cement, Ultra-Bond

510(k) Number

K760239 ↗

FDA Product Code

EMA

Device Class

Class II

Regulation

21 CFR Part 872.3275

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Impression Material, Triflex Silicone

  Class II

  FDA 510(k) K760240 Active Cleared 26 Jul 1976

• Impression Material, Triflex Silicone

  Class II

  FDA 510(k) K760238 Active Cleared 26 Jul 1976

• What is Ultra-Bond Cement used for in dental procedures?

  Ultra-Bond Cement is a dental adhesive designed specifically to bond dental restorations, such as porcelain or composite fillings, to natural tooth structure. Its purpose is to create a durable and stable connection, ensuring the restoration remains securely in place during and after the restorative procedure.

• How is Ultra-Bond Cement supplied, and is it intended for single-use?

  Ultra-Bond Cement is supplied as a single-use adhesive system. This design ensures sterility and safety for each clinical application, preventing cross-contamination between patients. Each package is intended for one-time use only.

• Is Ultra-Bond Cement sterile, and if so, how should it be stored?

  The provided data does not explicitly state whether Ultra-Bond Cement is sterile. However, as it is a single-use adhesive system for clinical dental use, it is reasonable to assume it is packaged in a sterile manner. To maintain integrity, it should be stored in a clean, dry environment, away from direct sunlight, and protected from extreme temperatures. Always follow manufacturer guidelines for storage.

• Are there different sizes or models of Ultra-Bond Cement available?

  The data lists multiple registration numbers (e.g., 3012441963, 3038718579) associated with Ultra-Bond Cement, which may correspond to different sizes, packaging configurations, or variants. These variations are likely intended to accommodate different clinical needs, such as varying restoration sizes or procedural requirements. For precise details on available sizes or models, refer to the manufacturer’s product documentation.

• What regulatory pathway does Ultra-Bond Cement follow, and is it FDA-cleared?

  Ultra-Bond Cement is regulated under the FDA 510(k) clearance pathway and holds a clearance number (K760239). It is classified as a Class II medical device under regulation number 872.3275. This classification indicates that it has been deemed substantially equivalent to a predicate device and meets FDA requirements for safety and effectiveness in its intended use.