Concord 82

FDA 510(k) K011628 · Gateway Alloys, Inc.

Substantially Equivalent

510(k) numberK011628

Submission

Device name
Concord 82
Applicant
Gateway Alloys, Inc.
St. Charles, MO, US
Received
May 29, 2001
Decision date
July 16, 2001
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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

More from Dentsply International

510(k)DeviceDecision
K011661Concord 88EJT · Abbreviated 08/27/2001SE
K011659Gpw-SfEJT · Traditional 08/27/2001SE
K011626Concord 72EJT · Abbreviated 07/16/2001SE
K964950La Plata 28 (PM-28)EJT · Traditional 01/13/1997SE
K964949Aurora 53EJT · Traditional 01/13/1997SE
K964948Aurora 52 (PM-01)EJT · Traditional 01/13/1997SE
K964941El Dorado 40EJT · Traditional 01/13/1997SE
K964940Taos 28EJT · Traditional 01/13/1997SE
K964838Palladia 85 (PM-13)EJT · Traditional 12/20/1996SE
K964837Pacific 56 (CB-40)EJT · Traditional 12/20/1996SE

Questions and answers

When was Concord 82 cleared by the FDA?

Concord 82 (K011628) received a 510(k) decision of Substantially Equivalent on July 16, 2001, 48 days after the submission was received.

What is the product code of K011628?

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