KMW · Class II · 21 CFR 872.4120

FDA Product Code KMW: Handpiece, Rotary Bone Cutting

Leading manufacturers include Nakanishi, Inc..

9
Total
9
Cleared
130d
Avg days
1986
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Handpiece, Rotary Bone Cutting Devices (Product Code KMW)

9 devices
1–9 of 9

About Product Code KMW - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code KMW since 1986, with 9 receiving FDA clearance (average review time: 130 days).

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

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