Biouniversal PKF

FDA 510(k) K030435 · Ivoclar Vivadent, Inc.

Substantially Equivalent

510(k) numberK030435

Submission

Device name
Biouniversal PKF
Applicant
Ivoclar Vivadent, Inc.
Amherst, NY, US
Received
February 10, 2003
Decision date
April 15, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EJT – Alloy, Gold-Based Noble Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3060
Specialty
Dental

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K052463Prometal HN86EJT · Traditional Prometal Technologies10/14/2005SE
K041378Bio 60EJT · Traditional Kodent, Inc.08/02/2004SE
K040672Porta ReflexEJT · Traditional Wieland Dental + Technik GmbH & Co. KG05/27/2004SE
K040524Porta Solder 1090 WEJT · Traditional Wieland Dental + Technik GmbH & Co. KG05/20/2004SE
K040043NDX-40 AlloyEJT · Traditional Heraeus Kulzer, Inc.03/03/2004SE
K034049Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional Heraeus Kulzer,GmbH03/01/2004SE
K033279Gold Dental Casting AlloysEJT · Traditional Bego U.S.A.01/15/2004SE
K033446APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional We Dong Myung Dental Industrial Co., Ltd.11/13/2003SE
K033435E-Sarang 86, DM78, DM55EJT · Traditional We Dong Myung Dental Industrial Co., Ltd.11/12/2003SE
K032320Appollo 3 AlloyEJT · Traditional Dentsply International10/01/2003SE

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Questions and answers

When was Biouniversal PKF cleared by the FDA?

Biouniversal PKF (K030435) received a 510(k) decision of Substantially Equivalent on April 15, 2003, 64 days after the submission was received.

What is the product code of K030435?

The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.