DW 273 #1

FDA 510(k) K003632 · Ivoclar North America, Inc.

Substantially Equivalent

510(k) numberK003632

Submission

Device name
DW 273 #1
Applicant
Ivoclar North America, Inc.
Amherst, NY, US
Received
November 24, 2000
Decision date
December 20, 2000
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

More from Ivoclar Vivadent, Inc.

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K011491Helioseal Clear ChromaEBC · Traditional 08/16/2001SE
K011492In Ten-SEBF · Traditional 07/05/2001SE
K011490Modification to ExciteKLE · Traditional 06/27/2001SE
K011023D.Sign 96EJT · Traditional 05/02/2001SE
K011022Biouniversal PDFEJT · Traditional 05/02/2001SE
K010381D.Sign 30EJH · Traditional 03/06/2001SE
K010250Tetric Ceram HBEBF · Traditional 02/28/2001SE
K003293Excite DSCKLE · Traditional 02/06/2001SE
K003407Systemp.Desensitizer (Vivadent.Desensitizer)EMA · Traditional 01/26/2001SE

Questions and answers

When was DW 273 #1 cleared by the FDA?

DW 273 #1 (K003632) received a 510(k) decision of Substantially Equivalent on December 20, 2000, 26 days after the submission was received.

What is the product code of K003632?

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