Product code NYL— Dental

ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM

Classification name: Handpiece, Air-Powered, Root Canal Irrigation
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Total cleared: 5
First cleared: 2006-05-26
Most recent: 2021-12-02

FDA classification definition

“To clean the root canal prior to filling and used for root canal irrigation.”
— U.S. Food and Drug Administration, device classification record for product code NYL under 21 CFR 872.4200, via openFDA

Market context for product code NYL

FDA has cleared 5 devices under product code NYL between 2006 and 2021, filed by 5 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

20211 clearance
20161 clearance
20141 clearance
20101 clearance
20061 clearance

Top applicants under product code NYL

Sybron Endo1 clearance
Redent Nova, Ltd.1 clearance
Kerr Corporation1 clearance
Inter-Med, Inc.1 clearance
Air Techniques, Inc.1 clearance

Recent clearances under product code NYL

K211721 — PS SystemInter-Med, Inc.·2021-12-02
K162436 — EndoVac PureKerr Corporation·2016-12-21
K140685 — ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEMSybron Endo·2014-07-02
K100606 — VATEA ENDONTIC IRRIGATION SYSTEMRedent Nova, Ltd.·2010-05-28
K052271 — RINSENDOAir Techniques, Inc.·2006-05-26

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