RX 90

FDA 510(k) K833050 · Jeneric Ind.

Substantially Equivalent

510(k) numberK833050

Submission

Device name
RX 90
Applicant
Jeneric Ind.
Mchenry, IL, US
Received
September 7, 1983
Decision date
October 28, 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.

510(k)DeviceDecision
K862822Rexillium N. B. F.EJH · Traditional 09/02/1986SE
K862926Surgical VitexELE · Traditional 08/29/1986SE
K854878H40 Base Metal AlloyEJH · Traditional 01/30/1986SE
K844123RX CbyEJH · Traditional 01/09/1985SE
K844122RX CBGEJH · Traditional 01/09/1985SE
K840563RX C & B 20EJS · Traditional 05/01/1984SE
K840561RX ElanEJS · Traditional 05/01/1984SE
K840562Rex VEJH · Traditional 04/13/1984SE
K834560Vitex P.D.AEJH · Traditional 02/27/1984SE
K833774Naturelle II & Lite II-N72-N74-LEJS · Traditional 01/24/1984SE

Questions and answers

When was RX 90 cleared by the FDA?

RX 90 (K833050) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 51 days after the submission was received.

What is the product code of K833050?

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