KB58-KF

FDA 510(k) K922958 · Jeneric/Pentron, Inc.

Substantially Equivalent

510(k) numberK922958

Submission

Device name
KB58-KF
Applicant
Jeneric/Pentron, Inc.
Wallingford, CT, US
Received
June 18, 1992
Decision date
February 26, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EJS – Alloy, Other Noble Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3060
Specialty
Dental

Other 510(k)s with product code EJS

510(k)DeviceApplicantDecision
K041433Bright Gold XHEJS · Traditional Ivoclar Vivadent, Inc.08/19/2004SE
K040436Simidur SuperiorEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/05/2004SE
K022252Sterngold 1, Model 1127781EJS · Abbreviated Sterngold09/19/2002SE
K022469Eco E4EJS · Traditional Wieland Dental + Technik GmbH & Co. KG09/18/2002SE
K021367Sterngold 66, Model #1180230EJS · Abbreviated Sterngold05/16/2002SE
K020195Simidur S1SEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K020194Simidur KF PlusEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K020192Simidur S2EJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K014042D.Sign 84EJS · Traditional Ivoclar Vivadent, Inc.02/22/2002SE
K013809D.Sign 59EJS · Traditional Ivoclar Vivadent, Inc.02/07/2002SE

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K013542Dentin Conditioning and Adhesive System (BOND-1)KLE · Traditional 02/14/2002SE
K012231Avante Micro Crystal SystemEIH · Traditional 08/23/2001SE
K011748First Fill R.C.S.KIF · Traditional 08/03/2001SE
K010957Quell DesensitizerLBH · Traditional 06/25/2001SE
K011331JP Cast 40EJT · Traditional 06/22/2001SE
K011330JP Cast 50EJT · Traditional 06/22/2001SE
K011362Gold Core 73 LSEJT · Traditional 05/29/2001SE
K010044CosmicEJT · Traditional 02/09/2001SE

Questions and answers

When was KB58-KF cleared by the FDA?

KB58-KF (K922958) received a 510(k) decision of Substantially Equivalent on February 26, 1993, 253 days after the submission was received.

What is the product code of K922958?

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