La Plata 39

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

510(k) Number

K964789 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Gpw-Sf

  Class II

  FDA 510(k) K011659 Active Cleared 27 Aug 2001

• Solder Gpw

  Class II

  FDA 510(k) K964713 Active Cleared 16 Dec 1996

• Aurora 53

  Class II

  FDA 510(k) K964949 Active Cleared 13 Jan 1997

• Solder 585

  Class II

  FDA 510(k) K964707 Active Cleared 16 Dec 1996

• Pacific 52 (Cb-39)

  Class II

  FDA 510(k) K964464 Active Cleared 26 Nov 1996

• Palladia 85 (Pm-13)

  Class II

  FDA 510(k) K964838 Active Cleared 20 Dec 1996

See all devices from Gateway Alloys, Inc. →

• What types of dental procedures is the La Plata 39 alloy intended for, and why is it considered suitable for these applications?

  The La Plata 39 is designed specifically for dental restorations and prosthetics where biocompatibility and durability are essential. As a gold-based noble metal alloy, it meets FDA’s standards for dental noble metal alloys under Class II special controls, making it suitable for crowns, bridges, inlays, onlays, and other fixed prosthetics. Its noble metal composition reduces the risk of allergic reactions and ensures long-term stability in the oral environment.

• Is the La Plata 39 alloy single-use or reusable, and what does this mean for my practice’s workflow?

  The La Plata 39 alloy is intended for both single-use and reusable applications in dental procedures. This flexibility allows you to fabricate restorations for individual patients or repurpose the alloy for multiple cases, depending on your practice’s protocols. However, standard dental practice sterility protocols must still be followed if reusing components fabricated from this alloy.

• Does this alloy require special handling or storage conditions, and how should it be stored to maintain its integrity?

  The La Plata 39 alloy does not specify unique sterility requirements beyond standard dental practice protocols, so it can be stored under typical dental conditions. To preserve its properties, keep it in a clean, dry environment away from moisture or extreme temperatures. Since it’s supplied for fabrication, ensure it’s stored in a way that prevents contamination before use in restorations.

• Are there any compatibility concerns with MRI machines when using restorations made from this alloy?

  The La Plata 39 alloy has no noted MRI safety restrictions in its regulatory documentation. This means restorations fabricated from it are generally considered safe for patients to undergo MRI scans, though clinicians should always verify compatibility with their specific MRI equipment and follow manufacturer guidelines for dental alloys.