Home / 510(k) Clearances / K943942

510(k) K943942

TRAV-LER KIT by John O. Butler Co. — Product Code JEQ

K943942 is an FDA 510(k) premarket notification submitted by John O. Butler Co. for the device "TRAV-LER KIT". The FDA issued a decision of Substantially Equivalent (kit) on March 8, 1995. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. John O. Butler Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 8, 1995
Date Received
August 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Toothbrush, Powered
Device Class
Class I
Regulation Number
872.6865
Review Panel
DE
Submission Type

Other clearances by John O. Butler Co.

  • K022900 — BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES (November 14, 2002)
  • K974761 — BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (June 16, 1998)
  • K952091 — VUTLER G.U.M. WITH FLUORIDE (June 28, 1995)
  • K950993 — BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH (June 2, 1995)
  • K874194 — PROTECT DROPS/SAME AS K874070 (December 16, 1987)

Other clearances for product code JEQ

  • K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit (August 27, 2020)
  • K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBR (September 15, 2014)
  • K061351 — ORAL-B SONIC COMPLETE (June 5, 2006)
  • K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES (May 31, 2006)
  • K040416 — SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 (July 2, 2004)
  • K022900 — BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES (November 14, 2002)
  • K012914 — SONICWAVE SONIC PLAQUE REMOVER (October 1, 2001)
  • K970381 — POWERED TOOTHBRUSH (April 18, 1997)
  • K945248 — HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH (January 26, 1995)
  • K944084 — JENERIC/PENTRON P0WERED TOOTHBRUST (December 20, 1994)

FDA data resources