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510(k) K141018

ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT by Procter & Gamble Co. — Product Code JEQ

K141018 is an FDA 510(k) premarket notification submitted by Procter & Gamble Co. for the device "ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT". The FDA issued a decision of Substantially Equivalent on September 15, 2014. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Procter & Gamble Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2014
Date Received
April 21, 2014
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 Procter & Gamble Co.

  • K203567 — Oral-B Dry Mouth Oral Rinse (April 5, 2021)
  • K201277 — Oral-B Dry Mouth Oral Rinse (September 2, 2020)
  • K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit (August 27, 2020)
  • K151413 — Always/Tampax bladder supports (December 18, 2015)
  • K133244 — TAMPAX M PLASTIC TAMPONS, UNSCENTED (January 9, 2014)
  • K131543 — TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED (June 20, 2013)
  • K113699 — TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED (January 12, 2012)
  • K110669 — TAMPAX C PLASTIC TAMPONS, UNSCENTED (June 2, 2011)
  • K091281 — TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL (June 1, 2010)
  • K091964 — CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS (September 24, 2009)

Other clearances for product code JEQ

  • K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit (August 27, 2020)
  • 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)
  • 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