.585 Fine Gold Solder

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

510(k) Number

K895052 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Low Fusing White Gold

  Class II

  FDA 510(k) K895056 Active Cleared 19 Dec 1989

• Silver-Free Ceramic Solder (Sfcs)

  Class II

  FDA 510(k) K902372 Active Cleared 28 Jun 1990

• Silhouette Porcelain

  Class II

  FDA 510(k) K895888 Active Cleared 10 Apr 1990

• Monogram III

  Class II

  FDA 510(k) K895065 Active Cleared 18 Dec 1989

• Select 40

  Class II

  FDA 510(k) K895069 Active Cleared 19 Dec 1989

• Select 50

  Class II

  FDA 510(k) K895068 Active Cleared 18 Dec 1989

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• What is the primary use of the .585 Fine Gold Solder in dental procedures?

  The .585 Fine Gold Solder is specifically designed for soldering dental restorations, such as crowns, bridges, and inlays. Its gold-based noble metal alloy provides high strength and corrosion resistance, ensuring durable and biocompatible dental prosthetics that are suitable for long-term use.

• Is this solder intended for single-use or reusable applications?

  The .585 Fine Gold Solder is intended for single-use in dental soldering procedures. It must be handled in a controlled environment to maintain its integrity, as reuse is not recommended or supported by the manufacturer.

• How is this product supplied, and does it come in sterile form?

  The .585 Fine Gold Solder is supplied in either sterile or non-sterile form, depending on the specific application requirements. The data does not specify which form is standard, so it’s important to confirm the sterility status with the manufacturer or supplier before use.

• What regulatory pathway was followed for FDA clearance of this product?

  The .585 Fine Gold Solder received FDA clearance through a 510(k) process (K895052) with a traditional review, which involved the Dental Advisory Committee (DE). The device is classified under FDA regulation number 872.3060 and was determined to be substantially equivalent to a predicate device.

• Are there any specific storage requirements for this solder?

  While the data does not provide explicit storage instructions, since the solder is intended for single-use in a controlled dental environment, it should be stored in a clean, dry place away from contaminants or moisture to preserve its integrity until use.