D.SIGN 84

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

510(k) Number

K014042 ↗

FDA product code

EJS

Device class

Class II

Regulation

21 CFR Part 872.3060

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

• Ips E.max Cad/Ips E.max Zircad Open recall

  Class II

  FDA 510(k) K051705 Active Cleared 14 Oct 2005

• Empress Direct

  Class II

  FDA 510(k) K090701 Active Cleared 29 Apr 2009

• Adhese 2

  Class II

  FDA 510(k) K252450 Active Cleared 5 Mar 2026

• Tetric Evoceram

  Class II

  FDA 510(k) K042819 Active Cleared 9 Nov 2004

• Tetric plus Fill

  Class II

  FDA 510(k) K261485 Active Cleared 1 Jul 2026

• Bluephase

  Class II

  FDA 510(k) K033520 Active Cleared 5 Dec 2003

See all devices from Ivoclar Vivadent, Inc. →

• What types of dental restorations can the D.SIGN 84 alloy be used to fabricate, and why is it suitable for these applications?

  The D.SIGN 84 alloy is designed for creating dental restorations such as onlays, inlays, partial crowns, single crowns, and telescope/conus crowns. It is suitable for these applications because its high palladium content (75.2%) and noble metal composition provide mechanical properties—such as a hardness of 295 HV and tensile strength of 117 N/mm²—that ensure durability and longevity. Additionally, it is engineered to match the physical properties of the IPS d.SIGN fluorapatite glass-ceramic, ensuring compatibility and aesthetic consistency in dental restorations.

• Is the D.SIGN 84 alloy reusable, and if so, how should it be handled to maintain its integrity?

  Yes, the D.SIGN 84 alloy is supplied as a reusable dental alloy, intended for use in both dental laboratories and clinical settings. Since it is reusable, proper handling and maintenance—such as cleaning, sterilization, and storage per manufacturer guidelines—are essential to preserve its mechanical properties and prevent degradation over repeated use. The alloy’s composition, including noble metals like palladium, contributes to its durability, but adherence to standard dental alloy processing protocols is critical.

• What regulatory pathway does the D.SIGN 84 alloy follow, and what does this mean for its use in dental practices?

  The D.SIGN 84 alloy follows the FDA 510(k) clearance pathway, specifically under the classification of a Class II dental device (product code EJS). It was determined to be *substantially equivalent* to a legally marketed predicate device and adheres to dental alloy standards (regulation number 872.3060). This means it has undergone FDA review to ensure safety and effectiveness for its intended use in dental restorations, providing confidence in its reliability for fabricating durable and aesthetically pleasing prosthetics like crowns and inlays.

• How does the composition of the D.SIGN 84 alloy contribute to its suitability for dental restorations?

  The D.SIGN 84 alloy’s composition—particularly its high palladium content (75.2%) along with trace elements like gold, indium, and ruthenium—gives it mechanical properties optimized for dental applications. The alloy’s hardness (295 HV) and tensile strength (117 N/mm²) ensure it can withstand the functional demands of restorations such as crowns and inlays. Additionally, its noble metal content enhances biocompatibility and aesthetic matching with adjacent dental structures, making it ideal for high-stress areas in the mouth.