DeviceClearance

Product code ELS— Dental

ENDIX RADICULAR BIOCERAMIC PIN

Classification name
Splint, Endodontic Stabilizing
Device class
Class 2
Regulation
21 CFR 872.3890
Advisory panel
Dental
Total cleared
6
First cleared
Most recent

Market context for product code ELS

FDA has cleared 6 devices under product code ELS between 1980 and 1997, filed by 6 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 ELS

Recent clearances under product code ELS

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