Cleared Traditional

K914198 - POWER FLOSS AND BRUSH EW 129 & EW 120

K914198 is an FDA 510(k) clearance for POWER FLOSS AND BRUSH EW 129 & EW 120, manufactured by Matsushita Electric Co.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914198 · Matsushita Electric Co. · Dental device
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Dec 1991
Decision
90d
Days
Class 1
Risk

K914198 is an FDA 510(k) clearance for the POWER FLOSS AND BRUSH EW 129 & EW 120. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Matsushita Electric Co. (Washington, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 90 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 Matsushita Electric Co. devices

FDA 510(k) Submission Details - K914198

510(k) Number K914198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1991
Decision Date December 18, 1991
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 10
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K914198.
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K935561 · Bausch & Lomb, Inc. · Jan 1994
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K926246 · Omron Healthcare, Inc. · Apr 1993
OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
K926247 · Omron Healthcare, Inc. · Apr 1993
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K910610 · Bausch & Lomb, Inc. · Jul 1991