DeviceClearance

Product code EKO— Dental

ADVANCED DENTURE SYSTEM

Classification name
Denture Preformed (Partially Prefabricated Denture)
Device class
Class 2
Regulation
21 CFR 872.3600
Advisory panel
Dental
Total cleared
4
First cleared
Most recent

Market context for product code EKO

FDA has cleared 4 devices under product code EKO between 1976 and 1990, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code EKO

Recent clearances under product code EKO

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