NUW · Class II · 21 CFR 890.5850

FDA Product Code NUW: Stimulator, Muscle, Powered, Dental

Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow.

Leading manufacturers include BTL Industries, Inc..

9
Total
9
Cleared
128d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 203d recently vs 119d historically

FDA 510(k) Cleared Stimulator, Muscle, Powered, Dental Devices (Product Code NUW)

9 devices
1–9 of 9
Cleared May 09, 2025
BTL-785MJ
K243290
BTL Industries, Inc.
Dental · 203d

About Product Code NUW - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code NUW since 1977, with 9 receiving FDA clearance (average review time: 128 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under NUW have taken an average of 203 days to reach a decision - up from 119 days historically. Manufacturers should account for longer review timelines in current project planning.

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