PORTABLE TOOTHBRUSH KIT (NO SAMPLE)— 510(k) K812361

Substantially Equivalent

Jdm Commodities

FDA 510(k) clearance K812361 for PORTABLE TOOTHBRUSH KIT (NO SAMPLE), Substantially Equivalent on 1981-11-20. Applicant: Jdm Commodities.

Clearance details

Applicant
Jdm Commodities
Product code
Code EFW
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EFW

product code EFW
Injury
143
Malfunction
698
Total
841

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.