Porta Ip Solder V-2

Q: What is the product code of K022467?

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

FDA 510(k) K022467 · Wieland Dental + Technik GmbH & Co. KG

Substantially Equivalent

510(k) numberK022467

Submission

Device name: Porta Ip Solder V-2
Applicant: Wieland Dental + Technik GmbH & Co. KG
Pforzheim, DE
Received: July 26, 2002
Decision date: September 17, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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

Other 510(k)s with product code EJT

510(k)	Device	Applicant	Decision
K052463	Prometal HN86EJT · Traditional	Prometal Technologies	10/14/2005SE
K041378	Bio 60EJT · Traditional	Kodent, Inc.	08/02/2004SE
K040672	Porta ReflexEJT · Traditional	Wieland Dental + Technik GmbH & Co. KG	05/27/2004SE
K040524	Porta Solder 1090 WEJT · Traditional	Wieland Dental + Technik GmbH & Co. KG	05/20/2004SE
K040043	NDX-40 AlloyEJT · Traditional	Heraeus Kulzer, Inc.	03/03/2004SE
K034049	Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional	Heraeus Kulzer,GmbH	03/01/2004SE
K033279	Gold Dental Casting AlloysEJT · Traditional	Bego U.S.A.	01/15/2004SE
K033446	APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional	We Dong Myung Dental Industrial Co., Ltd.	11/13/2003SE
K033435	E-Sarang 86, DM78, DM55EJT · Traditional	We Dong Myung Dental Industrial Co., Ltd.	11/12/2003SE
K032320	Appollo 3 AlloyEJT · Traditional	Dentsply International	10/01/2003SE

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Questions and answers

When was Porta Ip Solder V-2 cleared by the FDA?

Porta Ip Solder V-2 (K022467) received a 510(k) decision of Substantially Equivalent on September 17, 2002, 53 days after the submission was received.

What is the product code of K022467?

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