EGM — Injector, Jet, Mechanical-Powered Class II

FDA Device Classification

Classification Details

Product Code
EGM
Device Class
Class II
Regulation Number
872.4475
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243427dentalhitecQuickSleeper 5August 1, 2025
K083811w and h dentalwerk buermoosW&H HANDPIECE ANESTO, MODEL: RA-5January 14, 2010
K964802intra vantageCYBERJET LOCAL ANESTHESIA SYSTEMMay 27, 1997
K962017american jet injectorHYPODERMIC JET INJECTION APPARATUSJuly 26, 1996
K904279ronvig instrumentsPAROJECT ANESTHETIC SYRINGEDecember 7, 1990
K864294smith and nephewHENKE-JECT PRESSURE SYRINGE (MODIFICATION)November 4, 1987
K864732gradtechGRADTECH SYRINGE SYSTEMApril 15, 1987
K864861instrumentations unltdINSTRUMENTATIONS UNLIMITED SYRINGE SYSTEMFebruary 13, 1987
K834361c.b.s. biotechnicsJSB JET SYRINGEMarch 5, 1984
K821273conpharMAYO SCISSOR STRAIGHT 6 3/4May 28, 1982
K790193mizzyMIZZY SYRIJET MARK IVApril 23, 1979