EGM · Class II · 21 CFR 872.4475

FDA Product Code EGM: Injector, Jet, Mechanical-powered

Leading manufacturers include Dentalhitec.

11
Total
11
Cleared
163d
Avg days
1979
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 269d recently vs 152d historically

FDA 510(k) Cleared Injector, Jet, Mechanical-powered Devices (Product Code EGM)

11 devices
1–11 of 11
Cleared Aug 01, 2025
QuickSleeper 5
K243427
Dentalhitec
Dental · 269d

About Product Code EGM - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code EGM since 1979, with 11 receiving FDA clearance (average review time: 163 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 EGM have taken an average of 269 days to reach a decision - up from 152 days historically. Manufacturers should account for longer review timelines in current project planning.

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