Heritage Special Alloy

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

510(k) Number

K771110 ↗

FDA Product Code

EJT

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 the Heritage Special Alloy be used to create, and how is it processed?

  The Heritage Special Alloy is designed for casting dental crowns and porcelain-fused-to-metal bridge restorations. It is supplied as a reusable material intended for melting and casting in dental laboratories or clinics, ensuring structural integrity and biocompatibility for long-term use in patients.

• Is the Heritage Special Alloy intended for single-use or can it be reused in multiple dental procedures?

  The Heritage Special Alloy is explicitly described as a reusable dental material. It is meant to be melted down and recast multiple times for fabricating dental restorations, making it cost-effective for dental laboratories and clinics.

• How is the regulatory status of this alloy determined, and what standards does it comply with?

  The Heritage Special Alloy is classified as a Class II device under FDA regulations and was granted 510(k) clearance through a traditional review process. It complies with FDA’s Special Controls for dental alloys, which include requirements for noble metal content and performance in dental applications, ensuring safety and effectiveness for its intended use.

• Where is this alloy primarily used, and what kind of facilities would benefit from it?

  This alloy is intended for use in dental laboratories and clinics where crowns and porcelain-fused-to-metal bridges are fabricated. Facilities that require high-quality, biocompatible materials for casting dental prosthetics would benefit from its structural integrity and reusable nature.