PLAK SMACKER— 510(k) K852400

Substantially Equivalent

Plak Smacker Toothbrush Co.

FDA 510(k) clearance K852400 for PLAK SMACKER, Substantially Equivalent on 1985-07-01. Applicant: Plak Smacker Toothbrush Co..

Clearance details

Applicant: Plak Smacker Toothbrush Co.
Product code: Code EFW
Advisory panel: Dental
Date received: 1985-06-06
Decision date: 1985-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Corna, CA, US

Download summary PDF View on FDA.gov ↗

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.