EJIClass II
Syringe, Cartridge
21 CFR 872.6770 / Dental
EJI is the FDA product code for Syringe, Cartridge, a class II device type, regulated under 21 CFR 872.6770. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- EJI
- Device name
- Syringe, Cartridge
- Regulation
- 21 CFR 872.6770
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 45
- Ingested recalls
- 1
Clearances, product code EJI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 1 |
| 1982 | 2 |
| 1983 | 2 |
| 1984 | 3 |
| 1985 | 1 |
| 1988 | 1 |
| 1990 | 3 |
| 1992 | 1 |
| 1994 | 3 |
| 1995 | 3 |
| 1996 | 3 |
| 1997 | 2 |
| 1999 | 2 |
| 2000 | 3 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| 2012 | 2 |
| 2014 | 1 |
| 2017 | 1 |
Applicants with the most clearances
Product code EJI| Applicant | Clearances |
|---|---|
| Spintech, Inc. | 3 |
| Smith & Nephew, Mpl Division | 2 |
| Aalba Dent, Inc. | 1 |
| Advanced Technology and Capital, Inc. | 1 |
| Alan J. Khedarri D.D.S., Inc. | 1 |
| Anthogyr | 1 |
| Arent Fox | 1 |
| Arnold Tuber Industries | 1 |
| Astra Pharmaceutical Products, Inc. | 1 |
| Bma Technologies S.A. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.