DW260 19

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

510(k) Number

K954837 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• D-Sign VI (R&D Project DW266#9)

  Class II

  FDA 510(k) K990235 Active Cleared 1 Mar 1999

• Biouniversal Pdf

  Class II

  FDA 510(k) K011022 Active Cleared 2 May 2001

• Fermit N Plus

  Class II

  FDA 510(k) K003377 Active Cleared 4 Dec 2000

• Tetric Flow

  Class II

  FDA 510(k) K993783 Active Cleared 13 Dec 1999

• Sr-Isosit Spectra Link System

  Class II

  FDA 510(k) K910069 Active Cleared 2 Mar 1992

• Basic Calcium Hydroxide Liner

  Class II

  FDA 510(k) K896529 Active Cleared 16 Jan 1990

See all devices from Ivoclar North America, Inc. →

• What is the DW260 19 alloy used for in dental restorations?

  The DW260 19 is a gold-based noble metal alloy designed specifically for fabricating dental restorations such as inlays, onlays, and crowns. Its composition ensures high durability and biocompatibility, making it suitable for long-term use in oral environments where stability and patient safety are critical.

• Is the DW260 19 alloy reusable or single-use?

  The DW260 19 alloy is supplied as a reusable dental alloy. It is intended to be melted and recast multiple times for creating dental restorations in both dental laboratories and clinical settings, provided it adheres to proper safety and sterility protocols during handling and storage.

• What regulatory approval does the DW260 19 alloy hold?

  The DW260 19 alloy holds FDA 510(k) clearance under the reference number K954837, classified as a Class 2 medical device under product code EJT. This clearance confirms its substantial equivalence to a predicate device and compliance with dental material safety standards for use in restorative applications.

• How should the DW260 19 alloy be stored to maintain integrity?

  The DW260 19 alloy must be stored and handled according to dental material safety protocols to preserve sterility and integrity before use. Proper storage conditions, such as protection from contamination and environmental exposure, are essential to ensure the alloy remains suitable for melting and casting into dental restorations.

• What distinguishes the DW260 19 alloy from other dental alloys?

  The DW260 19 alloy is distinguished by its gold-based noble metal composition, which provides superior biocompatibility and long-term durability in oral environments. Unlike some alternatives, it is engineered specifically for high-performance dental restorations like inlays and crowns, ensuring reliability and patient safety in both laboratory and clinical settings.