Class of Casting Alloys Type II or Alter

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

510(k) Number

K820433 ↗

FDA Product Code

EJS

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Howmedica(R) Fully Threaded Screws

  Class II

  FDA 510(k) K974720 Active Cleared 13 Mar 1998

• Alta Femoral Intramedullary Rods/Cfx Rods Modification

  Class II

  FDA 510(k) K935295 Active Cleared 11 Oct 1994

• Naso-Gard Nasogastric Tube Holder

  Class II

  FDA 510(k) K801511 Active Cleared 28 Jul 1980

• Class of Casting Alloys Type III or Alt

  Class II

  FDA 510(k) K820434 Active Cleared 11 Mar 1982

• Howmedica Zirconia Ceramic Femoral Head

  Class II

  FDA 510(k) K945090 Active Cleared 19 Jan 1995

• Extended Balljoint Grip

  Class II

  FDA 510(k) K802723 Active Cleared 19 Nov 1980

See all devices from Howmedica Corp. →

• What types of dental restorations can this casting alloy be used to fabricate, and how is it typically applied in a dental lab?

  This CLASS OF CASTING ALLOYS TYPE II OR ALTER by Howmedica Corp. is specifically designed for precision casting in dental prosthetics, enabling the fabrication of metal dental restorations such as crowns, bridges, and inlays. In a dental lab, the alloy is melted and cast into molds to create durable, biocompatible restorations tailored to a patient’s oral anatomy. It is intended for single-use applications in laboratory settings, where each casting is used once before disposal.

• Is this alloy sterile, and if not, what hygiene practices should be followed when handling it in a dental lab?

  This casting alloy is not sterile by design, as it is meant for use in controlled dental laboratory environments. Standard laboratory hygiene practices—such as clean work surfaces, proper storage, and adherence to dental material handling protocols—are recommended to ensure safety and prevent contamination. No additional sterility requirements beyond these general practices are specified.

• How is this device regulated, and what does the FDA clearance indicate about its safety and performance?

  This alloy is regulated under the FDA 510(k) clearance process (K820433) and classified as a Class II device under special controls. The clearance indicates that the manufacturer has demonstrated substantial equivalence to a legally marketed predicate device, meaning it meets established safety and performance standards for dental casting alloys. The approval specifically pertains to its use in precision casting for dental restorations and does not imply broader clinical indications.

• Are there multiple sizes or models of this casting alloy, and if so, how are they differentiated?

  The provided data lists multiple registration numbers (e.g., 3003103749, 3009300369) associated with this alloy, which may correspond to different lot batches, formulations, or minor variations (e.g., Type II or