Partial Denture Alloy (K860437)

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

Full name

Partial Denture Alloy

510(k) Number

K860437 ↗

FDA Product Code

EJH

Device Class

Class II

Regulation

21 CFR Part 872.3710

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What is the Partial Denture Alloy (K860437) used for?

  The Partial Denture Alloy (K860437) is specifically designed for constructing removable partial denture frameworks. Its primary purpose is to provide a durable, corrosion-resistant base for supporting prosthetic teeth, ensuring long-term functionality and patient comfort. This alloy meets dental industry standards for material safety and performance, making it ideal for dental laboratories to melt, cast, or shape into custom frameworks.

• How is the Partial Denture Alloy supplied, and is it single-use?

  The Partial Denture Alloy (K860437) is supplied in bulk or pre-processed forms for use in dental laboratories. Unlike single-use devices, this alloy is reusable in its raw state before fabrication. It requires processing—such as melting, casting, or shaping—into partial denture frameworks before clinical application. Once fabricated into a denture, it is intended for patient use.

• Is sterility or MRI safety information provided for this alloy?

  No specific sterility or MRI safety information is provided for the Partial Denture Alloy (K860437). The alloy is intended for laboratory processing into denture frameworks, and its sterility or MRI compatibility would depend on the final fabricated product, not the raw material itself. Clinicians should follow standard dental protocols for sterilization of completed dentures.

• What regulatory pathway does this alloy follow, and what class is it assigned?

  The Partial Denture Alloy (K860437) is regulated under the FDA’s 510(k) clearance pathway and is classified as a Class II medical device with special controls. This classification is defined under regulation number 872.3710, and it falls under product code EJH as a metal base alloy. The device was granted substantial equivalence in 1986 through a traditional 510(k) review process.

• Can this alloy be used for other dental applications besides partial dentures?

  While the Partial Denture Alloy (K860437) is specifically designed for constructing removable partial denture frameworks, its properties—such as durability and corrosion resistance—may make it suitable for other dental applications requiring similar material characteristics. However, its intended use is strictly for partial denture frameworks, and any alternative applications would require validation by dental professionals or regulatory bodies to ensure safety and efficacy.