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510(k) K061351

ORAL-B SONIC COMPLETE by Braun GmbH — Product Code JEQ

K061351 is an FDA 510(k) premarket notification submitted by Braun GmbH for the device "ORAL-B SONIC COMPLETE". The FDA issued a decision of Substantially Equivalent on June 5, 2006. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Braun GmbH has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2006
Date Received
May 15, 2006
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 Braun GmbH

  • K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES (May 31, 2006)
  • K060006 — BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER (January 31, 2006)
  • K031928 — BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCA (October 24, 2003)
  • K012035 — BRAUN PRECISION SENSOR PRO, MODEL BP 2590 (July 27, 2001)
  • K003732 — BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES (May 16, 2001)
  • K992468 — BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER (October 20, 1999)
  • K983295 — BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 (March 15, 1999)
  • K844339 — BRAUN DENTAL CENTER OC-3 (February 8, 1985)

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)
  • 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)
  • 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