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510(k) K040436

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2004
Date Received
February 19, 2004
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

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Other clearances for product code EJS

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  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
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  • 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)