Will-Ceram W-3

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K771596 ↗

FDA Product Code

EJS

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Dura-Vac

  Not classified

  FDA 510(k) K770545 Active Cleared 24 Mar 1977

• Renaissance

  Class II

  FDA 510(k) K844395 Active Cleared 9 Jan 1985

• Will-Ceram Y-2

  Class II

  FDA 510(k) K760122 Active Cleared 16 Jul 1976

• Disposable Articulator

  Class I

  FDA 510(k) K801342 Active Cleared 8 Jul 1980

• A Thenium

  Class II

  FDA 510(k) K821510 Active Cleared 9 Jun 1982

• Gold, 24 Karat Casting

  Class II

  FDA 510(k) K781788 Active Cleared 28 Dec 1978

See all devices from Williams Gold Refining Co., Inc. →

• What types of dental restorations is the Will-Ceram W-3 alloy specifically designed for, and why is it considered suitable for these applications?

  The Will-Ceram W-3 is designed for dental restorations such as inlays, onlays, and crowns. It is considered suitable for these applications due to its classification as an *Alloy, Other Noble Metal*, which provides high durability and biocompatibility—critical properties for long-term dental restorations that require strength and compatibility with oral tissues.

• Is the Will-Ceram W-3 alloy single-use or reusable, and how does this affect its clinical use?

  The Will-Ceram W-3 is explicitly described as a *reusable dental material*, meaning it can be used multiple times after proper cleaning and sterilization. This makes it cost-effective for clinical settings where multiple restorations may be fabricated, though sterilization protocols must be followed to ensure safety and prevent contamination between uses.

• What regulatory pathway was followed for the Will-Ceram W-3, and what does this mean for its use in dental practices?

  The Will-Ceram W-3 was cleared through the FDA’s *510(k) process* (K771596) with a *Substantially Equivalent (SESE)* determination, meaning it was deemed comparable to a legally marketed predicate device. This clearance places it under *Dental Device Class II* regulation, ensuring it meets established safety and effectiveness standards for dental alloys. Clinicians can rely on this classification for confidence in its performance and compliance.

• Are there any special storage requirements for the Will-Ceram W-3 alloy, and if so, why?

  The provided data does not specify any unique storage requirements beyond standard handling for dental alloys. However, since it is a reusable material, it should be stored in a clean, dry environment to prevent contamination or degradation before use. Proper packaging and protection from moisture or physical damage are generally recommended for dental alloys to maintain their integrity and performance.