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510(k) K914513

PALAVIT G by Heraeus Kulzer, Inc. — Product Code EGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1992
Date Received
October 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wax, Dental, Intraoral
Device Class
Class I
Regulation Number
872.6890
Review Panel
DE
Submission Type

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  • K113574 — FLEXITIME MONOPHASE PRO SCAN (July 13, 2012)
  • K112501 — VENUS PEARL PLT REFILL A1 (December 14, 2011)
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  • K101617 — FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CAR (September 7, 2010)
  • K093575 — GLUMA DESENSITIZER POWER GEL (March 5, 2010)

Other clearances for product code EGD

  • K020009 — BRACE EZE (February 11, 2002)
  • K945535 — GLENROE ORTHO-SIL (January 27, 1995)
  • K924024 — ORTHO WAX (November 17, 1992)
  • K923586 — BURNOUT MATERIAL (September 29, 1992)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K922380 — BITE RIM WAX (June 16, 1992)
  • K910676 — INTRAORAL DENTAL WAX (August 21, 1991)
  • K904928 — PALAVIT GLC (June 6, 1991)
  • K895566 — PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT (November 6, 1989)
  • K895564 — PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD (November 6, 1989)