Product code EJW— Dental

ORTHODONTIC NITINOL SPRINGS

Classification name: Clasp, Wire
Device class: Class 1
Regulation: 21 CFR 872.3285
Advisory panel: Dental
Total cleared: 3
First cleared: 1987-07-21
Most recent: 1990-04-25

Market context for product code EJW

FDA has cleared 3 devices under product code EJW between 1987 and 1990, 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

19901 clearance
19881 clearance
19871 clearance

Top applicants under product code EJW

Ivoclar North America, Inc.1 clearance
Flexmedics1 clearance
Austenal Dental, Inc.1 clearance

Recent clearances under product code EJW

K901257 — WIRONTOM CLASP WIREIvoclar North America, Inc.·1990-04-25
K881331 — ORTHODONTIC NITINOL SPRINGSFlexmedics·1988-04-21
K872746 — VITALLIUM WIREAustenal Dental, Inc.·1987-07-21

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