Cleared Traditional

K940288 - WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT

K940288 is an FDA 510(k) clearance for WATER PIK SENSONIC PLAQUE REMOVAL INSTR..., manufactured by Teledyne Water Pik. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K940288 · Teledyne Water Pik · Dental device
Download Printable Device Report (PDF)
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May 1994
Decision
125d
Days
Class 1
Risk

K940288 is an FDA 510(k) clearance for the WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Teledyne Water Pik (Fort Collins, US). The FDA issued a Cleared decision on May 26, 1994 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6865 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K940288

510(k) Number K940288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date May 26, 1994
Days to Decision 125 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 128d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

JEQ Device Classification - Class 1, General Controls

Product Code JEQ Toothbrush, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6865
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JEQ Toothbrush, Powered

All 35
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K940288.
PEMBUSH
K942634 · Crossroads Trading Co. · Sep 1994
MY BEAT POWERED TOOTHBRUSH
K941209 · Sanwa Components USA, Inc. · Jun 1994
ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH
K941243 · Oraline, Ltd. · Jun 1994
SONIPLAK
K935150 · American Dentronics, Inc. · May 1994
SONIFLOSS
K935148 · American Dentronics, Inc. · Jan 1994
SONIBRUSH
K935149 · American Dentronics, Inc. · Jan 1994
K940288 · WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT
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