REACH ANTIBACTERIAL TOOTHBRUSH— 510(k) K971589

Substantially Equivalent

Personal Products Co.

FDA 510(k) clearance K971589 for REACH ANTIBACTERIAL TOOTHBRUSH, Substantially Equivalent on 1997-07-24. Applicant: Personal Products Co..

Clearance details

Applicant: Personal Products Co.
Product code: Code EFW
Advisory panel: Dental
Date received: 1997-05-01
Decision date: 1997-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, NJ, 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.