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510(k) K880607

UTILITY WAX STRIPS, SPEARMINT by Columbus Dental Mfg. Co. — Product Code EGD

K880607 is an FDA 510(k) premarket notification submitted by Columbus Dental Mfg. Co. for the device "UTILITY WAX STRIPS, SPEARMINT". The FDA issued a decision of Substantially Equivalent on March 31, 1988. The device falls under product code EGD (Wax, Dental, Intraoral), a Class I device regulated under 21 CFR 872.6890. Columbus Dental Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1988
Date Received
February 12, 1988
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)
  • 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)
  • K863758 — ORTHO-BITE WAX WAFER (October 7, 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)
  • K895563 — PEMACO BITE WAX SHEETS (November 6, 1989)

FDA data resources