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..

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

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.

NYL devices are reviewed by the Dental panel. Browse all Dental devices →