Cleared Traditional

K021383 - ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL

K021383 is an FDA 510(k) clearance for ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL, manufactured by Agion Technologies, LLC. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K021383 · Agion Technologies, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
76d
Days
Class 1
Risk

K021383 is an FDA 510(k) clearance for the ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Agion Technologies, LLC (Wakefield, US). The FDA issued a Cleared decision on July 17, 2002 after a review of 76 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.

FDA 510(k) Submission Details - K021383

510(k) Number K021383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2002
Decision Date July 17, 2002
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 128d · This submission: 76d
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 29
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K021383.
BEAM BRUSH/BEAM APP
K121165 · Beam Technologies, LLC · Jun 2012
SILVER CARE ANITBACTERIAL TOOTHBRUSH
K102871 · Piave Spazzolificio S.P.A. · Oct 2011
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
K073224 · Procter & Gamble · Feb 2008
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
K020776 · Coronet Group North America, LLC · Jun 2002
LAZERSMILE, LAZERWHITE
K000290 · Biolase Technology, Inc. · Apr 2000
TOOTHBRUSH WASH
K994144 · Cal Huech, Inc. · Mar 2000
K021383 · ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
Download PDF FDA Summary Agion Technologies, L…