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510(k) K952091

VUTLER G.U.M. WITH FLUORIDE by John O. Butler Co. — Product Code JES

K952091 is an FDA 510(k) premarket notification submitted by John O. Butler Co. for the device "VUTLER G.U.M. WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. John O. Butler Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1995
Date Received
May 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Floss, Dental
Device Class
Class I
Regulation Number
872.6390
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)
  • K950993 — BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH (June 2, 1995)
  • K943942 — TRAV-LER KIT (March 8, 1995)
  • K874194 — PROTECT DROPS/SAME AS K874070 (December 16, 1987)

Other clearances for product code JES

  • K091964 — CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS (September 24, 2009)
  • K964976 — FLOSSBRUSH WITH FLUORIDE (May 6, 1997)
  • K963746 — IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORID (December 12, 1996)
  • K944034 — PERIO-MED DENTAL FLOSS (July 25, 1995)
  • K951917 — JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS (May 10, 1995)
  • K942689 — RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE (April 27, 1995)
  • K943157 — ORAL-B ULTRAFLOSS WITH FLLUORIDE (April 27, 1995)
  • K942690 — RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (April 27, 1995)
  • K944886 — COLGATE PRECISION MINT WZXED DENTAL FLOSS (April 27, 1995)
  • K935440 — JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED (February 3, 1994)

FDA data resources