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510(k) K864709

IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL by Ivoclar USA, Inc. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1987
Date Received
December 2, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
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)
  • K923644 — DW243-64 (November 4, 1992)
  • K864708 — SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN (February 25, 1987)
  • K864710 — ISOSIT N (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)

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