K130186

Substantially Equivalent

DENTEK EASY BRUSH WITH FLUORIDE

Applicant: Den Tek Oral Care, Inc.
Product code: EFW
Advisory panel: Dental
Date received: 2013-01-25
Decision date: 2013-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maryville, TN, US

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.