510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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EGMClass II

Injector, Jet, Mechanical-Powered

21 CFR 872.4475 / Dental
FDA source (opens on fda.gov)

EGM is the FDA product code for Injector, Jet, Mechanical-Powered, a class II device type, regulated under 21 CFR 872.4475. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EGM
Device name
Injector, Jet, Mechanical-Powered
Regulation
21 CFR 872.4475
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
11
Ingested recalls
0

Clearances, product code EGM

By decision year
11 clearances under product code EGM with a decision year between 1979 and 2025, 1987 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code EGM by decision year
YearClearances
19791
19821
19841
19873
19901
19961
19971
20101
20251

Applicants with the most clearances

Product code EGM
Applicants holding the most 510(k) clearances under product code EGM
ApplicantClearances
American Jet Injector Corp.1
C.B.S. Biotechnics, Inc.1
Conphar, Inc.1
Dentalhitec1
Gradtech1
Instrumentations Unltd.1
Intra Vantage, Inc.1
Mizzy, Inc.1
Ronvig Instruments, Ltd.1
Smith & Nephew, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code