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Platalloy

FDA 510(k)

Class II (US FDA 510(k))

510(k) K972607

by Aalba Dent, Inc.

Identifiers

510(k) Number
K972607 FDA 510(k)
FDA Product Code
EJH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3710 FDA 510(k)
Regulation Number
872.3710 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Platalloy is a base metal alloy used for dental restorative prosthetic devices. It is a nickel-chromium alloy designed for casting dental prosthetics.

Platalloy is supplied as a metal alloy for dental laboratory use. It is a Class II device cleared by the FDA under product code EJH and regulation number 872.3710. The device is manufactured by Aalba Dent, Inc. in Fairfield, California.

Frequently asked questions

What is PLATALLOY used for in dental applications?

PLATALLOY is a base metal alloy specifically designed for casting dental restorative prosthetic devices. It is formulated as a nickel-chromium alloy that dental laboratories use to create various dental prosthetics.

How is PLATALLOY supplied and what is its intended use?

PLATALLOY is supplied as a metal alloy specifically for dental laboratory use. It is not intended for direct patient use but rather as a material that dental professionals use to fabricate prosthetic devices in a laboratory setting.

What is the regulatory classification of PLATALLOY?

PLATALLOY is classified as a Class II device cleared by the FDA under product code EJH and regulation number 872.3710. It received FDA clearance through the traditional 510(k) process with a substantial equivalence determination.

Is PLATALLOY single-use or reusable?

The device data does not specify whether PLATALLOY is single-use or reusable. As a metal alloy supplied for laboratory use, it is typically used in the fabrication process rather than being applied directly to patients, but the specific reuse policy would depend on laboratory protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Aalbadent | Base Metal Restorative Alloys, Aalba Dent - LinkedIn, Aalba Dent, Inc. | (707) 864-3334 | Fairfield, California - AllBiz, AALBA DENT INC. - Address, Director information

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aalba Dent, Inc.

Sources (1)

  • FDA 510(k) K972607 24 fields · synced Sep 24, 2026