NYL · Class I · 21 CFR 872.4200

FDA Product Code NYL: Handpiece, Air-powered, Root Canal Irrigation

To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation.

Leading manufacturers include Inter-Med, Inc., Air Techniques, Inc. and Redent-Nova , Ltd..

5
Total
5
Cleared
153d
Avg days
2006
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Handpiece, Air-powered, Root Canal Irrigation Devices (Product Code NYL)

5 devices
1–5 of 5
Cleared Dec 02, 2021
PS System
K211721
Inter-Med, Inc.
Dental · 181d
Cleared Dec 21, 2016
EndoVac Pure
K162436
Kerr Corporation
Dental · 112d
Cleared Jul 02, 2014
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
K140685
Sybron Endo
Dental · 106d
Cleared May 28, 2010
VATEA ENDONTIC IRRIGATION SYSTEM
K100606
Redent-Nova , Ltd.
Dental · 86d
Cleared May 26, 2006
RINSENDO
K052271
Air Techniques, Inc.
Dental · 280d

About Product Code NYL - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code NYL since 2006, with 5 receiving FDA clearance (average review time: 153 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.