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510(k) K040416

SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 by Philips Oral Healthcare, Inc. — Product Code JEQ

K040416 is an FDA 510(k) premarket notification submitted by Philips Oral Healthcare, Inc. for the device "SONICARE ADVANCE TOOTHBRUSH, MODEL 4900". The FDA issued a decision of Substantially Equivalent on July 2, 2004. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2004
Date Received
February 18, 2004
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 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)
  • K022900 — BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES (November 14, 2002)
  • K012914 — SONICWAVE SONIC PLAQUE REMOVER (October 1, 2001)
  • K970381 — POWERED TOOTHBRUSH (April 18, 1997)
  • K943942 — TRAV-LER KIT (March 8, 1995)
  • K945248 — HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH (January 26, 1995)
  • K944084 — JENERIC/PENTRON P0WERED TOOTHBRUST (December 20, 1994)

FDA data resources