DeviceClearance

Product code EKS— Dental

A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)

Classification name
File, Pulp Canal, Endodontic
Device class
Class 1
Regulation
21 CFR 872.4565
Advisory panel
Dental
Total cleared
31
First cleared
Most recent

Market context for product code EKS

FDA has cleared 31 devices under product code EKS between 1980 and 2006, filed by 25 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 EKS

Adverse events under product code EKS

product code EKS
Malfunction
1,949
Total
1,949

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 EKS

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