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510(k) K020195

SIMIDUR S1S by Wieland Dental + Technik GmbH & Co. KG — Product Code EJS

K020195 is an FDA 510(k) premarket notification submitted by Wieland Dental + Technik GmbH & Co. KG for the device "SIMIDUR S1S". The FDA issued a decision of Substantially Equivalent on March 15, 2002. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Wieland Dental + Technik GmbH & Co. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2002
Date Received
January 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Other Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by Wieland Dental + Technik GmbH & Co. KG

  • K152118 — Zenostar MT, Zenostar Color Liquids (December 16, 2015)
  • K151142 — IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID (August 13, 2015)
  • K142233 — zenostar MO, Zenostar T, Zenostar VisualiZr (January 5, 2015)
  • K130184 — ZENOLUX (May 24, 2013)
  • K112710 — ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR (October 17, 2011)
  • K103773 — ZENOFLEX DIMENSION (March 16, 2011)
  • K103494 — ZENOSTAR MAGIC GLAZE (February 16, 2011)
  • K082257 — ZENO AI ECO DISC (September 18, 2008)
  • K080182 — ZENO PMMA DISC (April 8, 2008)
  • K073108 — ZENO ZR DISC (November 21, 2007)

Other clearances for product code EJS

  • K041433 — BRIGHT GOLD XH (August 19, 2004)
  • K040436 — SIMIDUR SUPERIOR (March 5, 2004)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K022469 — ECO E4 (September 18, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020192 — SIMIDUR S2 (March 15, 2002)
  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)
  • K014082 — D.SIGN 53, MODEL NA1012204 (January 30, 2002)

FDA data resources