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510(k) K904928

PALAVIT GLC by Kulzer, Inc. — Product Code EGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1991
Date Received
October 31, 1990
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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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)
  • K914513 — PALAVIT G (March 19, 1992)
  • K910676 — INTRAORAL DENTAL WAX (August 21, 1991)
  • K895566 — PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT (November 6, 1989)
  • K895564 — PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD (November 6, 1989)