Cleared Traditional

K940288 - WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT (FDA 510(k) Clearance)

Class I Dental device.

K940288 · Teledyne Water Pik · Dental device
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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.

View all Teledyne Water Pik devices

Submission Details

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
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.