EGM — Injector, Jet, Mechanical-Powered Class II
FDA product code EGM covers "Injector, Jet, Mechanical-Powered", a Class II medical device regulated under 21 CFR 872.4475. Submissions are reviewed by the Dental panel. At least 11 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243427 | dentalhitec | QuickSleeper 5 | August 1, 2025 |
| K083811 | w and h dentalwerk buermoos | W&H HANDPIECE ANESTO, MODEL: RA-5 | January 14, 2010 |
| K964802 | intra vantage | CYBERJET LOCAL ANESTHESIA SYSTEM | May 27, 1997 |
| K962017 | american jet injector | HYPODERMIC JET INJECTION APPARATUS | July 26, 1996 |
| K904279 | ronvig instruments | PAROJECT ANESTHETIC SYRINGE | December 7, 1990 |
| K864294 | smith and nephew | HENKE-JECT PRESSURE SYRINGE (MODIFICATION) | November 4, 1987 |
| K864732 | gradtech | GRADTECH SYRINGE SYSTEM | April 15, 1987 |
| K864861 | instrumentations unltd | INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM | February 13, 1987 |
| K834361 | c.b.s. biotechnics | JSB JET SYRINGE | March 5, 1984 |
| K821273 | conphar | MAYO SCISSOR STRAIGHT 6 3/4 | May 28, 1982 |
| K790193 | mizzy | MIZZY SYRIJET MARK IV | April 23, 1979 |