DeviceClearance

Product code EFB— Dental

DENTAL HANDPIECE

Classification name
Handpiece, Air-Powered, Dental
Device class
Class 1
Regulation
21 CFR 872.4200
Advisory panel
Dental
Total cleared
261
First cleared
Most recent

Market context for product code EFB

FDA has cleared 261 devices under product code EFB between 1976 and 2026, filed by 144 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 EFB

Adverse events under product code EFB

product code EFB
Injury
133
Malfunction
562
Total
695

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 EFB

1–100 of 261

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