ODONTO TOOTHBRUSH— 510(k) K852691

Name: FDA 510(k) clearance K852691
Creator: U.S. Food and Drug Administration
Published: 1985-09-27

Substantially Equivalent

Action Hygiene Products, Inc.

FDA 510(k) clearance K852691 for ODONTO TOOTHBRUSH, Substantially Equivalent on 1985-09-27. Applicant: Action Hygiene Products, Inc.. Device class: 1.

Clearance details

Applicant: Action Hygiene Products, Inc.
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1985-06-26
Decision date: 1985-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada M3j 2b9, CA

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
K021383 — ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL2002-07-17

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.