FDA product code EJI: Syringe, Cartridge
EJI is the FDA product code for syringe, cartridge. It is a Class II device, regulated under 21 CFR 872.6770 and reviewed by the Dental panel. FDA has cleared 45 510(k) submissions under EJI, from 42 different applicants. The average 510(k) review took 138 days (median 84). FDA has posted 1 recall for EJI devices.
Classification
| Field | Value |
|---|---|
| Device name | Syringe, Cartridge |
| Device class | Class II |
| Regulation | 21 CFR 872.6770 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
510(k) clearances per year for EJI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 202 |
Compare with all 510(k) review times · Search every EJI clearance
Top EJI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spintech, Inc. | 3 | 2003-09-02 |
| Smith & Nephew, Mpl Division | 2 | 1984-09-27 |
| Advanced Technology and Capital, Inc. | 1 | 2017-11-16 |
| Integra LifeSciences Corporation | 1 | 2014-10-30 |
| Hu-Friedy Mfg. Co., LLC | 1 | 2012-11-06 |
37 more applicants have EJI clearances. See the full list in Caduvo.
Most recent EJI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171254 | Advanced Technology and Capital, Inc. | LeEject 2 Dental Syringe and Needle System | 2017-11-16 | 202 |
| K142414 | Integra LifeSciences Corporation | Miltex N-Tralig Intraligamentary Syringe | 2014-10-30 | 63 |
| K120659 | Hu-Friedy Mfg. Co., LLC | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | 2012-11-06 | 246 |
| K113247 | Ki Works Co., Ltd. | ANESTHESIA INJECTION TOOL SET | 2012-03-27 | 146 |
| K082249 | Meibach Tech Ltda | MORPHEUS | 2009-12-31 | 510 |
Recalls for EJI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-11.
Frequently asked questions
What is FDA product code EJI?
EJI is the FDA product code for syringe, cartridge. It is a Class II device, regulated under 21 CFR 872.6770 and reviewed by the Dental panel.
What device class is EJI?
Class II, regulation 21 CFR 872.6770. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJI?
Across 45 cleared submissions the average was 138 days from receipt to decision (median 84).
Which companies have the most EJI clearances?
Spintech, Inc. (3); Smith & Nephew, Mpl Division (2); Advanced Technology and Capital, Inc. (1); Integra LifeSciences Corporation (1); Hu-Friedy Mfg. Co., LLC (1).
Have EJI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-02-11.
Next steps
- Run an FDA pathway report with predicate devices for product code EJI
- Run a recall and safety report across every EJI manufacturer
- Watch product code EJI 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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