DeviceClearance

Product code EFW— Dental

BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER

Classification name
Toothbrush, Manual
Device class
Class 1
Regulation
21 CFR 872.6855
Advisory panel
Dental
Total cleared
49
First cleared
Most recent

Market context for product code EFW

FDA has cleared 49 devices under product code EFW between 1976 and 2013, filed by 42 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code EFW

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 →

Recent clearances under product code EFW

Data sourced from openFDA. This site is unofficial and independent of the FDA.