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510(k) K923644

DW243-64 by Ivoclar USA, Inc. — Product Code EJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1992
Date Received
July 21, 1992
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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  • K864707 — SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH (February 10, 1987)
  • K863421 — SR-IVOLEN TRAY MATERIAL (November 3, 1986)
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Other clearances for product code EJS

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  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)