FDA product code EJB: Handle, Instrument, Dental
EJB is the FDA product code for handle, instrument, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under EJB, from 8 different applicants. The average 510(k) review took 124 days (median 70). FDA has posted 1 recall for EJB devices.
Classification
| Field | Value |
|---|---|
| Device name | Handle, Instrument, Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EJB clearance
Top EJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centrix, Inc. | 1 | 2014-07-08 |
| Neks Technologies | 1 | 2003-06-25 |
| Lone Star Technologies | 1 | 1998-06-05 |
| Aukland Medical Plastics, Inc. | 1 | 1993-10-20 |
| E&D Dental Products, Inc. | 1 | 1992-08-06 |
3 more applicants have EJB clearances. See the full list in Caduvo.
Most recent EJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140144 | Centrix, Inc. | BENDA WEDGE | 2014-07-08 | 167 |
| K023367 | Neks Technologies | DETECTAR, MODEL N123-MI | 2003-06-25 | 260 |
| K981234 | Lone Star Technologies | FLARE,FILE, FILL | 1998-06-05 | 62 |
| K930094 | Aukland Medical Plastics, Inc. | AUKUSLEEVE | 1993-10-20 | 285 |
| K922633 | E&D Dental Products, Inc. | CAVI-ZYME | 1992-08-06 | 78 |
Recalls for EJB devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-05-09.
Frequently asked questions
What is FDA product code EJB?
EJB is the FDA product code for handle, instrument, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EJB?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJB?
Across 8 cleared submissions the average was 124 days from receipt to decision (median 70).
Which companies have the most EJB clearances?
Centrix, Inc. (1); Neks Technologies (1); Lone Star Technologies (1); Aukland Medical Plastics, Inc. (1); E&D Dental Products, Inc. (1).
Have EJB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-05-09.
Next steps
- Run an FDA pathway report with predicate devices for product code EJB
- Run a recall and safety report across every EJB manufacturer
- Watch product code EJB 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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