EGM
11 FDA 510(k) clearances · Product code
130 daysmedian time to decision
369 days90th percentile
11clearances measured
FDA profile
- Official device name
- Injector, Jet, Mechanical-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.4475
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1995: 1 · 1997: 1 · 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QuickSleeper 5 (K243427) | Dentalhitec | 2025-08-01 |
| W&H HANDPIECE ANESTO, MODEL: RA-5 (K083811) | W&H Dentalwerk Buermoos GmbH | 2010-01-14 |
| CYBERJET LOCAL ANESTHESIA SYSTEM (K964802) | Intra Vantage, Inc. | 1997-05-27 |
| HYPODERMIC JET INJECTION APPARATUS (K962017) | American Jet Injector Corp. | 1996-07-26 |
| PAROJECT ANESTHETIC SYRINGE (K904279) | Ronvig Instruments, Ltd. | 1990-12-07 |
| HENKE-JECT PRESSURE SYRINGE (MODIFICATION) (K864294) | Smith & Nephew, Inc. | 1987-11-04 |
| GRADTECH SYRINGE SYSTEM (K864732) | Gradtech | 1987-04-15 |
| INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM (K864861) | Instrumentations Unltd. | 1987-02-13 |
| JSB JET SYRINGE (K834361) | C.B.S. Biotechnics, Inc. | 1984-03-05 |
| MAYO SCISSOR STRAIGHT 6 3/4 (K821273) | Conphar, Inc. | 1982-05-28 |
| MIZZY SYRIJET MARK IV (K790193) | Mizzy, Inc. | 1979-04-23 |
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Every clearance here is in the API, with alerts when new ones post.