Cleared Traditional

K020776 - MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS

K020776 is an FDA 510(k) clearance for MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOS..., manufactured by Coronet Group North America, LLC. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K020776 · Coronet Group North America, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
84d
Days
Class 1
Risk

K020776 is an FDA 510(k) clearance for the MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Coronet Group North America, LLC (Queensbury,, US). The FDA issued a Cleared decision on June 3, 2002 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - 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 Coronet Group North America, LLC devices

FDA 510(k) Submission Details - K020776

510(k) Number K020776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2002
Decision Date June 03, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

EFW Device Classification - Class 1, General Controls

Product Code EFW Toothbrush, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
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 - EFW Toothbrush, Manual

All 13
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K020776.
DENTEK EASY BRUSH WITH FLUORIDE
K130186 · Den Tek Oral Care, Inc. · Jul 2013
BEAM BRUSH/BEAM APP
K121165 · Beam Technologies, LLC · Jun 2012
LAZERSMILE, LAZERWHITE
K000290 · Biolase Technology, Inc. · Apr 2000
TOOTHBRUSH WASH
K994144 · Cal Huech, Inc. · Mar 2000
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
K992435 · Azo Enterprises · Oct 1999
PLAQ-ATAQ-I
K980995 · Ethicare · Aug 1998