EGM

Injector, Jet, Mechanical-Powered

Product code
EGM
Device name
Injector, Jet, Mechanical-Powered
Device class
Class 2
21 CFR
21 CFR 872.4475
Medical specialty
Dental
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
11 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-08-01.

NumberDecision dateApplicantDevice nameSummary
K2434272025-08-01DentalhitecQuickSleeper 5PDF

1 summaries are archived here for direct download.

Official FDA classification page: EGM
Classification and pathway per current FDA publications. Data from openFDA (CC0).