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510(k) K863758

ORTHO-BITE WAX WAFER by Columbus Dental Mfg. Co. — Product Code EGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1986
Date Received
September 25, 1986
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 Columbus Dental Mfg. Co.

  • K880754 — DRI-CLAVE LIQUID KLEENZALL (May 12, 1988)
  • K880607 — UTILITY WAX STRIPS, SPEARMINT (March 31, 1988)
  • K880606 — UTILITY WAX STRIPS, CINNAMON (March 24, 1988)
  • K872243 — PEKALUX(TM) (July 7, 1987)
  • K872272 — PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS (July 2, 1987)
  • K871164 — GLUMA(TM) BONDING SYSTEM (July 2, 1987)
  • K871165 — LUMIFOR(TM) COMPOSITE (April 3, 1987)
  • K863816 — IVORY PREMIUM RUBBER DAM (October 27, 1986)
  • K860855 — SHUR GEL 4 (June 16, 1986)
  • K830083 — SHUR GEL (February 7, 1983)

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)
  • K895566 — PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT (November 6, 1989)