FDA product code EKB: Explorer, Operative
EKB is the FDA product code for explorer, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EKB, from 3 different applicants. The average 510(k) review took 37 days (median 24). FDA has posted 7 recalls for EKB devices.
Classification
| Field | Value |
|---|---|
| Device name | Explorer, 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 EKB clearance
Top EKB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-07-02 |
| Treace Medical, Inc. | 1 | 1983-01-21 |
| Pacific Dental Corp. | 1 | 1982-07-06 |
Most recent EKB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851724 | Artiberia | 1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS | 1985-07-02 | 68 |
| K823914 | Treace Medical, Inc. | EXPLORER TIP | 1983-01-21 | 24 |
| K821780 | Pacific Dental Corp. | BEACH EXPLORER NO. 23T.G. | 1982-07-06 | 19 |
Recalls for EKB devices
7 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-01-07.
Frequently asked questions
What is FDA product code EKB?
EKB is the FDA product code for explorer, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKB?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKB?
Across 3 cleared submissions the average was 37 days from receipt to decision (median 24).
Which companies have the most EKB clearances?
Artiberia (1); Treace Medical, Inc. (1); Pacific Dental Corp. (1).
Have EKB devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2005-01-07.
Next steps
- Run an FDA pathway report with predicate devices for product code EKB
- Run a recall and safety report across every EKB manufacturer
- Watch product code EKB 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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