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510(k) K950993

BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH by John O. Butler — Product Code EFW

K950993 is an FDA 510(k) premarket notification submitted by John O. Butler for the device "BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH". The FDA issued a decision of Substantially Equivalent on June 2, 1995. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855. John O. Butler has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1995
Date Received
March 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Toothbrush, Manual
Device Class
Class I
Regulation Number
872.6855
Review Panel
DE
Submission Type

Other clearances by John O. Butler

  • 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)
  • K943942 — TRAV-LER KIT (March 8, 1995)
  • K874194 — PROTECT DROPS/SAME AS K874070 (December 16, 1987)

Other clearances for product code EFW

  • K130186 — DENTEK EASY BRUSH WITH FLUORIDE (July 15, 2013)
  • K121165 — BEAM BRUSH/BEAM APP (June 21, 2012)
  • K102871 — SILVER CARE ANITBACTERIAL TOOTHBRUSH (October 3, 2011)
  • K073224 — ORAL-B SUB-BRAND MANUAL TOOTHBRUSH (February 6, 2008)
  • K021383 — ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL (July 17, 2002)
  • K020776 — MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS (June 3, 2002)
  • K000290 — LAZERSMILE, LAZERWHITE (April 14, 2000)
  • K994144 — TOOTHBRUSH WASH (March 2, 2000)
  • K992435 — BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER (October 15, 1999)
  • K980995 — PLAQ-ATAQ-I (August 20, 1998)

FDA data resources