X-704

FDA 510(k) K832253 · Unitek Corp.

Substantially Equivalent

510(k) numberK832253

Submission

Device name
X-704
Applicant
Unitek Corp.
Mchenry, IL, US
Received
July 11, 1983
Decision date
August 31, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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K940165AlastikECI · Traditional 03/07/1994SE
K923999Alastik NSECI · Traditional 06/24/1993SE
K924645Transcend Series 6000 Debonding InstrumentsJEX · Traditional 11/25/1992SE
K924295Debracketing InstrumentJEX · Traditional 11/23/1992SE
K923432German Mini DynalockEJF · Traditional 10/30/1992SE
K911271Adhesive Precoated BracketsDYH · Traditional 05/29/1991SE
K910288Nonstaining AlastiksEJF · Traditional 03/29/1991SE
K890529AlastigardEJF · Traditional 03/09/1989SE

Questions and answers

When was X-704 cleared by the FDA?

X-704 (K832253) received a 510(k) decision of Substantially Equivalent on August 31, 1983, 51 days after the submission was received.

What is the product code of K832253?

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