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BioUniversal PKF

FDA 510(k)

Class II (US FDA 510(k))

510(k) K030435

by Ivoclar Vivadent, Inc.

Identifiers

510(k) Number
K030435 FDA 510(k)
FDA Product Code
EJT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3060 FDA 510(k)
Regulation Number
872.3060 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

BioUniversal PKF is a palladium-based crown and bridge alloy used in dental applications. It is a gold-based noble metal alloy with composition including gold, platinum, silver, zinc, indium, iridium, iron, tantalum, and rhodium.

The device is supplied as a dental alloy for use in onlays, partial crowns, single crowns, and telescope restorations. It has a hardness of 165 HV and tensile strength of 89 N/mm², and is authorized under FDA 510(k) clearance K030435 with product code EJT and regulation number 872.3060.

Frequently asked questions

What is BioUniversal PKF used for in dental applications?

BioUniversal PKF is used for dental restorations including onlays, partial crowns, single crowns, and telescope restorations due to its composition as a palladium-based gold noble metal alloy.

How is BioUniversal PKF supplied and what are its key material properties?

BioUniversal PKF is supplied as a dental alloy with a hardness of 165 HV and tensile strength of 89 N/mm², composed of gold, platinum, silver, zinc, indium, iridium, iron, tantalum, and rhodium.

Is BioUniversal PKF a single-use or reusable device?

BioUniversal PKF is a dental alloy material intended for fabrication into restorations; it is not implanted or used directly, so reuse depends on the final restoration design and clinical protocol, not the alloy itself.

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: BioUniversal PKF - ivoclar.com, BioUniversal Pkf | Dental Alloys | Ivoclar CA, BioUniversal PKF Porcelain Alloy from Ivoclar Vivadent Inc., Ivoclar-vivadent BioUniversal PKF manuals

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ivoclar Vivadent, Inc.

Sources (1)

  • FDA 510(k) K030435 24 fields · synced Oct 6, 2026