Portalloy 54

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

510(k) Number

K021242 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Wieland Dental + Technik GmbH & Co. KG →

• What is Portalloy 54 used for in dental applications?

  Portalloy 54 is a gold-palladium ceramic alloy used by dental technicians to fabricate various dental appliances including crowns, short and long span bridges, removable partials, telescopic work, and milling work. It can be veneered with suitable dental ceramics and composites.

• How is Portalloy 54 supplied and what is its regulatory status?

  Portalloy 54 is supplied as a gold-based noble metal alloy. It is regulated under FDA 510(k) clearance with product code EJT and regulation number 872.3060, having been determined substantially equivalent to predicate devices.

• What are the specifications and characteristics of Portalloy 54?

  Portalloy 54 is a gold-palladium ceramic alloy specifically designed for dental applications. It is manufactured by Wieland Dental + Technik GmbH & Co. KG and received FDA 510(k) clearance on May 16, 2002, with the device classified under product code EJT.

• Can Portalloy 54 be used with different dental materials?

  Yes, Portalloy 54 can be veneered with suitable dental ceramics as well as dental composites, making it versatile for various dental restoration applications where both ceramic and composite materials may be used.