BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES— 510(k) K022900

Substantially Equivalent

John O. Butler Co.

FDA 510(k) clearance K022900 for BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES, Substantially Equivalent on 2002-11-14. Applicant: John O. Butler Co..

Clearance details

Applicant
John O. Butler Co.
Product code
Code JEQ
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chicago, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JEQ

product code JEQ
Injury
188
Malfunction
2,818
Total
3,006

Source: openFDA MAUDE database, through . 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.