Product code EKL— Dental

EAR PROBES

Classification name: Point, Silver, Endodontic
Device class: Class 1
Regulation: 21 CFR 872.3840
Advisory panel: Dental
Total cleared: 3
First cleared: 1982-09-14
Most recent: 1999-10-21

Market context for product code EKL

FDA has cleared 3 devices under product code EKL between 1982 and 1999, filed by 3 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

19991 clearance
19961 clearance
19821 clearance

Top applicants under product code EKL

Pulpdent Corp.1 clearance
Pacific Implant, Inc.1 clearance
Kelleher Corp.1 clearance

Recent clearances under product code EKL

K992582 — PACIFIC IMPLANT TITANIUM ENDODONTIC POINTPacific Implant, Inc.·1999-10-21
K961089 — PULPDENT ENDOPREP IIPulpdent Corp.·1996-04-23
K822568 — EAR PROBESKelleher Corp.·1982-09-14

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