Cleared Traditional

K931360 - ELECTRIC TOOTH-BRUSH

K931360 is an FDA 510(k) clearance for ELECTRIC TOOTH-BRUSH, manufactured by U.S. Dentek Corp.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K931360 · U.S. Dentek Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
118d
Days
Class 1
Risk

K931360 is an FDA 510(k) clearance for the ELECTRIC TOOTH-BRUSH. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by U.S. Dentek Corp. (Novato, US). The FDA issued a Cleared decision on July 13, 1993 after a review of 118 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 - K931360

510(k) Number K931360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date July 13, 1993
Days to Decision 118 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
10d faster than avg
Panel avg: 128d · This submission: 118d
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 47
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K931360.
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K935561 · Bausch & Lomb, Inc. · Jan 1994
ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH
K936076 · Ohio Health Care Products, Inc. · Jan 1994
PULSE ELECTRIC TOOTHBRUSH
K933829 · Dentatech Corp. · Dec 1993
OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
K926246 · Omron Healthcare, Inc. · Apr 1993
OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
K926247 · Omron Healthcare, Inc. · Apr 1993
SONEX ULTRASONIC TOOTH BRUSH
K913724 · Sonex Intl., Corp. · Dec 1992
K931360 · ELECTRIC TOOTH-BRUSH
Download PDF U.S. Dentek Corp.