ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL— 510(k) K021383

Name: FDA 510(k) clearance K021383
Creator: U.S. Food and Drug Administration
Published: 2002-07-17

Substantially Equivalent

Agion Technologies, LLC

FDA 510(k) clearance K021383 for ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL, Substantially Equivalent on 2002-07-17. Applicant: Agion Technologies, LLC. Device class: 1.

Clearance details

Applicant: Agion Technologies, LLC
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 2002-05-02
Decision date: 2002-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wakefield, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFW

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K130186 — DENTEK EASY BRUSH WITH FLUORIDE2013-07-15
K121165 — BEAM BRUSH/BEAM APP2012-06-21
K102871 — SILVER CARE ANITBACTERIAL TOOTHBRUSH2011-10-03
K073224 — ORAL-B SUB-BRAND MANUAL TOOTHBRUSH2008-02-06
K020776 — MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS2002-06-03

Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.