Cleared Traditional

K936076 - ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH

K936076 is an FDA 510(k) clearance for ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH, manufactured by Ohio Health Care Products, Inc.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K936076 · Ohio Health Care Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
37d
Days
Class 1
Risk

K936076 is an FDA 510(k) clearance for the ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Ohio Health Care Products, Inc. (Manassas, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 37 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ohio Health Care Products, Inc. devices

FDA 510(k) Submission Details - K936076

510(k) Number K936076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date January 26, 1994
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
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 7
Devices cleared under the same product code (JEQ) and FDA review panel - the closest regulatory comparables to K936076.
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
K141018 · Procter & Gamble Co. · Sep 2014
JENERIC/PENTRON P0WERED TOOTHBRUST
K944084 · Jeneric/Pentron, Inc. · Dec 1994
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K935561 · Bausch & Lomb, Inc. · Jan 1994
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
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K910610 · Bausch & Lomb, Inc. · Jul 1991