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510(k) K864707

SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH by Ivoclar USA, Inc. — Product Code ELM

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
Denture, Plastic, Teeth
Device Class
Class II
Regulation Number
872.3590
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)
  • K864709 — IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL (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 ELM

  • K132984 — SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S (January 14, 2014)
  • K122955 — DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM (March 1, 2013)
  • K122925 — NEW STETIC ARTIFICIAL TEETH (February 12, 2013)
  • K122852 — PHYSIOSTAR NFC (December 6, 2012)
  • K121749 — VERACIA (September 7, 2012)
  • K120404 — MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH (May 21, 2012)
  • K120736 — SR PHONARES II (May 14, 2012)
  • K113426 — VERACIA SA (February 8, 2012)
  • K101064 — BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P (September 14, 2010)
  • K101029 — KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYM (August 16, 2010)