Ney-Oro 41

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

510(k) Number

K870677 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Neydium Npflux (for Soldering)

  Not classified

  FDA 510(k) K770159 Active Cleared 31 Jan 1977

• Gdc-3338, Dental Solder Alloy

  Class II

  FDA 510(k) K920887 Active Cleared 19 Mar 1992

• Ultima Lite

  Class II

  FDA 510(k) K890568 Active Cleared 9 Mar 1989

• Gdc 1448 Development Name

  Class II

  FDA 510(k) K833596 Active Cleared 29 Dec 1983

• Gdc-685

  Class II

  FDA 510(k) K790641 Active Cleared 1 May 1979

• Tempo

  Class II

  FDA 510(k) K792274 Active Cleared 30 Nov 1979

See all devices from Deringer-Ney, Inc. →

• What types of dental procedures is the Ney-Oro 41 alloy specifically designed for, and why is it considered durable for oral use?

  The Ney-Oro 41 is a gold-based noble metal alloy intended for restorative dental procedures, such as crowns, bridges, or inlays, where long-term durability and biocompatibility are critical. Its gold-based composition provides resistance to corrosion and wear in the oral environment, ensuring stability over extended periods. This makes it suitable for applications requiring high strength and resistance to tarnishing, which is essential for maintaining patient comfort and oral health.

• Is the Ney-Oro 41 alloy reusable, and if so, how should it be handled to ensure proper use in clinical or laboratory settings?

  Yes, the Ney-Oro 41 is supplied as a reusable dental alloy, meaning it can be melted, reshaped, and reused multiple times in dental laboratories or clinical settings. Since it is not sterile by default, it must be cleaned, sterilized, and handled according to standard dental alloy reprocessing protocols to prevent contamination and ensure biocompatibility for patient use. Always follow manufacturer guidelines for melting, casting, and finishing to maintain its performance and safety.

• What regulatory pathway does the Ney-Oro 41 follow, and how does its classification impact its use in dental applications?

  The Ney-Oro 41 is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K870677, and classified as Class II (EJT). This classification indicates it is subject to special controls to ensure its safety and effectiveness for dental restorative use. The traditional 510(k) route confirms it is deemed substantially equivalent to a legally marketed predicate device, meaning it meets established performance standards for dental alloys. Clinicians and labs can rely on this regulatory backing when selecting it for procedures requiring durable, biocompatible materials.

• Are there any special storage requirements for the Ney-Oro 41 alloy, and how should it be stored to maintain its integrity?

  The provided data does not specify sterility or special storage conditions for the Ney-Oro 41 alloy, but as a reusable dental alloy, it should be stored in a clean, dry environment to prevent contamination or degradation. Since it is intended for melting and recasting, it should be kept in a sealed container or packaging to avoid exposure to moisture, dust, or chemicals that could compromise its composition or usability. Always follow the manufacturer’s instructions for storage to ensure optimal performance.