Valuline Amalgam Alloy

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

510(k) Number

K821971 ↗

FDA Product Code

EJJ

Device Class

Class II

Regulation

21 CFR Part 872.3070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Johnson & Johnson Professionals, Inc. →

• What is the Valuline Amalgam Alloy used for in dental procedures?

  The Valuline Amalgam Alloy is specifically designed for dental restorative procedures. It is intended for direct application in the oral cavity to repair cavities, restore tooth structure, and improve function. This alloy provides a durable filling material that helps maintain long-term dental integrity when used according to professional dental practice guidelines.

• Is the Valuline Amalgam Alloy single-use or reusable?

  The Valuline Amalgam Alloy is a reusable dental material. It is not intended for single-use applications. Proper handling and storage are required before and after use to maintain its integrity and ensure safe, effective performance in dental restorations.

• How should the Valuline Amalgam Alloy be stored?

  The Valuline Amalgam Alloy must be stored in accordance with standard dental practice protocols to preserve its quality and sterility. Since it is reusable, it should be kept in a clean, dry environment, away from moisture and extreme temperatures, to prevent degradation and ensure it remains suitable for professional dental use.

• What regulatory approval does the Valuline Amalgam Alloy hold?

  The Valuline Amalgam Alloy holds FDA 510(k) clearance (K821971) under 21 CFR 872.3070, demonstrating it is substantially equivalent to predicate devices. This approval confirms its compliance with U.S. regulatory standards for dental restorative alloys intended for professional use.

• Can the Valuline Amalgam Alloy be used by non-professionals?

  No, the Valuline Amalgam Alloy is intended exclusively for professional dental use. It requires specialized handling, application techniques, and adherence to dental protocols to ensure safety and effectiveness. Non-professional use is not recommended and may compromise dental health.