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510(k) K970381

POWERED TOOTHBRUSH by Emjoi Action USA, Ltd. — Product Code JEQ

K970381 is an FDA 510(k) premarket notification submitted by Emjoi Action USA, Ltd. for the device "POWERED TOOTHBRUSH". The FDA issued a decision of Substantially Equivalent on April 18, 1997. 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
April 18, 1997
Date Received
February 3, 1997
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

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  • 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)
  • 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