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510(k) K923644

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

K923644 is an FDA 510(k) premarket notification submitted by Ivoclar USA, Inc. for the device "DW243-64". The FDA issued a decision of Substantially Equivalent on November 4, 1992. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Ivoclar USA, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Ivoclar USA, Inc.

  • K012877 — HIGH GOLD PALLADIUM FREE CERAMIC SOLDER (November 21, 2001)
  • K981264 — ARISTON PHC (July 2, 1998)
  • K980986 — PROCAD (May 11, 1998)
  • K941849 — PROVIPONT C&B (August 17, 1994)
  • K864708 — SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN (February 25, 1987)
  • K864710 — ISOSIT N (February 10, 1987)
  • K864709 — IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL (February 10, 1987)
  • K864707 — SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH (February 10, 1987)
  • K863421 — SR-IVOLEN TRAY MATERIAL (November 3, 1986)
  • K844349 — SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS (December 3, 1984)

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)
  • K020195 — SIMIDUR S1S (March 15, 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)

FDA data resources