DENTEK EASY BRUSH WITH FLUORIDE— 510(k) K130186

Substantially Equivalent

Den Tek Oral Care, Inc.

FDA 510(k) clearance K130186 for DENTEK EASY BRUSH WITH FLUORIDE, Substantially Equivalent on 2013-07-15. Applicant: Den Tek Oral Care, Inc..

Clearance details

Applicant: Den Tek Oral Care, Inc.
Product code: 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

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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.