Howmedica A-35 Dental Alloy

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

510(k) Number

K791973 ↗

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 is the Howmedica A-35 Dental Alloy specifically designed for, and how is it used in the dental laboratory?

  The Howmedica A-35 Dental Alloy is designed exclusively for dental laboratories to fabricate cast or porcelain-fused-to-metal crowns and bridges. It is supplied in a form suitable for dental casting procedures, meaning it is melted and poured into molds to create precise restorations. The alloy’s noble metal composition—including gold, palladium, platinum, or silver—ensures durability and biocompatibility for long-term use in patients.

• Is the Howmedica A-35 Dental Alloy intended for reuse, or is it meant to be used only once in a dental laboratory?

  The Howmedica A-35 Dental Alloy is explicitly intended for single-use in dental laboratories. Since it is supplied for casting procedures, each batch is meant to be consumed during one fabrication cycle. Reuse is not recommended, as it could compromise the alloy’s integrity, sterility, or performance for patient restorations.

• What storage conditions should be followed to maintain the alloy’s integrity before use in dental casting?

  While the data does not specify exact storage conditions, the alloy’s single-use nature and sensitivity to handling imply it should be stored in a dry, sealed environment to prevent contamination or degradation. Proper storage ensures the alloy remains suitable for casting without oxidation or corrosion, which could affect the final restoration’s quality.

• How was the FDA clearance for this alloy determined, and what does the product code EJS indicate about its regulatory classification?

  The Howmedica A-35 Dental Alloy received FDA 510(k) clearance under the product code EJS, which falls under Class II special controls for dental devices. The clearance was granted as *Substantially Equivalent* (SESE) to a predicate device, meaning it was deemed comparable in safety and effectiveness to an already-approved dental alloy. The Dental (DE) advisory committee reviewed it, confirming its suitability for cast or porcelain-fused-to-metal restorations.