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510(k) K940288

WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT by Teledyne Water Pik — Product Code JEQ

K940288 is an FDA 510(k) premarket notification submitted by Teledyne Water Pik for the device "WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT". The FDA issued a decision of Substantially Equivalent on May 26, 1994. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Teledyne Water Pik has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1994
Date Received
January 21, 1994
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 Teledyne Water Pik

  • K970594 — KALGINATE IMPRESSION MATERIAL (March 31, 1997)
  • K952422 — ELASTIC IMPRESSION CREAM (August 29, 1995)
  • K944162 — DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (November 29, 1994)
  • K931380 — WATER PIK PLUS PLAQUE CONTROL SYSTEM (September 20, 1993)
  • K905188 — PERIO PIK (February 15, 1991)
  • K900547 — WATER PIK(R) W/ADD'L CLAIMS (June 15, 1990)
  • K895259 — PIK POCKET(R), MODEL PP-3 (November 1, 1989)
  • K894015 — WATER PIK(R) (August 28, 1989)

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)
  • 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)

FDA data resources