E-Z Gold Tooth Filling Material

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

510(k) Number

K915507 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• What is the E-Z Gold Tooth Filling Material used for?

  The E-Z Gold Tooth Filling Material is a gold-based noble metal alloy specifically formulated for dental restorative purposes. It is intended to repair damaged or decayed teeth by providing a durable, long-lasting filling solution that adheres to dental standards for noble metal alloys. Its design ensures strength and biocompatibility, making it suitable for restoring tooth structure while minimizing irritation or adverse reactions.

• Is the E-Z Gold Tooth Filling Material sterile or reusable?

  The E-Z Gold Tooth Filling Material is supplied for single-use applications in clinical settings. There is no indication in the provided specifications that it is sterile or intended for reuse. As a result, it should be handled and disposed of according to standard dental best practices for noble metal alloys to ensure patient safety and compliance with clinical protocols.

• What regulatory approval does the E-Z Gold Tooth Filling Material hold?

  The E-Z Gold Tooth Filling Material is regulated under the FDA 510(k) clearance process, with a clearance number of K915507. It is classified as a Class II device under product code EJT and is determined to be substantially equivalent to existing dental filling materials. This classification ensures it meets specific safety and performance standards for dental restorative materials.

• How should the E-Z Gold Tooth Filling Material be stored?

  While specific storage conditions are not detailed in the provided specifications, noble metal alloys like the E-Z Gold Tooth Filling Material should generally be stored in a clean, dry environment to prevent contamination or degradation. Adherence to standard dental storage practices—such as keeping materials in sealed packaging until use and protecting them from moisture or extreme temperatures—is recommended to maintain their integrity and effectiveness.

• What distinguishes the E-Z Gold Tooth Filling Material from other dental filling materials?

  The E-Z Gold Tooth Filling Material is distinguished by its formulation as a gold-based noble metal alloy, which provides enhanced durability, strength, and biocompatibility compared to other dental filling materials. This composition is particularly suited for long-term restorations where resistance to wear and corrosion is critical. Its FDA 510(k) clearance further validates its equivalence to existing dental standards, ensuring reliability for clinical use.