FDA product code EGM: Injector, Jet, Mechanical-Powered
EGM is the FDA product code for injector, jet, mechanical-powered. It is a Class II device, regulated under 21 CFR 872.4475 and reviewed by the Dental panel. FDA has cleared 11 510(k) submissions under EGM, 1 in the last five years, from 11 different applicants. The average 510(k) review took 163 days (median 130); 269 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Injector, Jet, Mechanical-Powered |
| Device class | Class II |
| Regulation | 21 CFR 872.4475 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EGM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 269 |
Compare with all 510(k) review times · Search every EGM clearance
Top EGM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentalhitec | 1 | 2025-08-01 |
| W&H Dentalwerk Buermoos GmbH | 1 | 2010-01-14 |
| Intra Vantage, Inc. | 1 | 1997-05-27 |
| American Jet Injector Corp. | 1 | 1996-07-26 |
| Ronvig Instruments, Ltd. | 1 | 1990-12-07 |
6 more applicants have EGM clearances. See the full list in Caduvo.
Most recent EGM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243427 | Dentalhitec | QuickSleeper 5 | 2025-08-01 | 269 |
| K083811 | W&H Dentalwerk Buermoos GmbH | W&H HANDPIECE ANESTO, MODEL: RA-5 | 2010-01-14 | 388 |
| K964802 | Intra Vantage, Inc. | CYBERJET LOCAL ANESTHESIA SYSTEM | 1997-05-27 | 179 |
| K962017 | American Jet Injector Corp. | HYPODERMIC JET INJECTION APPARATUS | 1996-07-26 | 64 |
| K904279 | Ronvig Instruments, Ltd. | PAROJECT ANESTHETIC SYRINGE | 1990-12-07 | 81 |
Recalls for EGM devices
openFDA lists no recalls for product code EGM.
Frequently asked questions
What is FDA product code EGM?
EGM is the FDA product code for injector, jet, mechanical-powered. It is a Class II device, regulated under 21 CFR 872.4475 and reviewed by the Dental panel.
What device class is EGM?
Class II, regulation 21 CFR 872.4475. Typical premarket route: 510(k).
How long does a 510(k) take for product code EGM?
Across 11 cleared submissions the average was 163 days from receipt to decision (median 130).
Which companies have the most EGM clearances?
Dentalhitec (1); W&H Dentalwerk Buermoos GmbH (1); Intra Vantage, Inc. (1); American Jet Injector Corp. (1); Ronvig Instruments, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EGM
- Run a recall and safety report across every EGM manufacturer
- Watch product code EGM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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