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510(k) K895563

PEMACO BITE WAX SHEETS by Pemaco, Inc. — Product Code EGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1989
Date Received
September 6, 1989
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

Other clearances by Pemaco, Inc.

  • K910676 — INTRAORAL DENTAL WAX (August 21, 1991)
  • K895564 — PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD (November 6, 1989)
  • K895566 — PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT (November 6, 1989)
  • K895562 — PEMACO 2000 INTRAORAL DENTAL WAX (November 6, 1989)
  • K895561 — PEMACO 3000 INTRAORAL DENTAL WAX (November 6, 1989)
  • K895565 — PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD (October 24, 1989)

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)
  • K904928 — PALAVIT GLC (June 6, 1991)
  • K895562 — PEMACO 2000 INTRAORAL DENTAL WAX (November 6, 1989)