DeviceClearance

Product code EFT— Dental

ARGILITE 4 GOLD ALLOY FOR PORCELAIN

Classification name
Cleanser, Denture, Over The Counter
Device class
Class 1
Regulation
21 CFR 872.3520
Advisory panel
Dental
Total cleared
26
First cleared
Most recent

Market context for product code EFT

FDA has cleared 26 devices under product code EFT between 1977 and 2008, filed by 24 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 EFT

Adverse events under product code EFT

product code EFT
Death
8
Injury
267
Total
275

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 EFT

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