FDA product code EKJ: Burnisher, Operative
EKJ is the FDA product code for burnisher, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 72 510(k) submissions under EKJ, from 46 different applicants. The average 510(k) review took 100 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Burnisher, Operative |
| 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 EKJ clearance
Top EKJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Medical Ceramics, Inc. | 11 | 1990-04-27 |
| Centrix, Inc. | 4 | 1993-09-15 |
| Dentsply Intl. | 3 | 1995-06-22 |
| Protector, Inc. | 3 | 1994-02-15 |
| Brevet, Inc. | 3 | 1989-12-04 |
41 more applicants have EKJ clearances. See the full list in Caduvo.
Most recent EKJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961714 | Distriflor S.A. | ASEPTYLUM, UNI-CARRIER | 1996-06-10 | 39 |
| K953707 | Medtrol, Inc. | MEDTROL DENTAL KIT | 1996-01-04 | 149 |
| K945815 | Constancy Ent., Inc. | DENTAL KIT | 1995-07-19 | 233 |
| K951607 | Dentsply Intl. | SUREFLEX FILES | 1995-06-22 | 98 |
| K945077 | Worldwide Dental, Inc. | INSTRUMENT,FILLING,PLASTIC,DENTAL | 1994-11-30 | 44 |
Recalls for EKJ devices
openFDA lists no recalls for product code EKJ.
Frequently asked questions
What is FDA product code EKJ?
EKJ is the FDA product code for burnisher, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKJ?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKJ?
Across 72 cleared submissions the average was 100 days from receipt to decision (median 62).
Which companies have the most EKJ clearances?
American Medical Ceramics, Inc. (11); Centrix, Inc. (4); Dentsply Intl. (3); Protector, Inc. (3); Brevet, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code EKJ
- Run a recall and safety report across every EKJ manufacturer
- Watch product code EKJ 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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