FDA product code EKL: Point, Silver, Endodontic
EKL is the FDA product code for point, silver, endodontic. It is a Class I device, regulated under 21 CFR 872.3840 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EKL, from 3 different applicants. The average 510(k) review took 45 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Point, Silver, Endodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.3840 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EKL clearance
Top EKL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pacific Implant, Inc. | 1 | 1999-10-21 |
| Pulpdent Corp. | 1 | 1996-04-23 |
| Kelleher Corp. | 1 | 1982-09-14 |
Most recent EKL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992582 | Pacific Implant, Inc. | PACIFIC IMPLANT TITANIUM ENDODONTIC POINT | 1999-10-21 | 80 |
| K961089 | Pulpdent Corp. | PULPDENT ENDOPREP II | 1996-04-23 | 35 |
| K822568 | Kelleher Corp. | EAR PROBES | 1982-09-14 | 21 |
Recalls for EKL devices
openFDA lists no recalls for product code EKL.
Frequently asked questions
What is FDA product code EKL?
EKL is the FDA product code for point, silver, endodontic. It is a Class I device, regulated under 21 CFR 872.3840 and reviewed by the Dental panel.
What device class is EKL?
Class I, regulation 21 CFR 872.3840. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKL?
Across 3 cleared submissions the average was 45 days from receipt to decision (median 35).
Which companies have the most EKL clearances?
Pacific Implant, Inc. (1); Pulpdent Corp. (1); Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EKL
- Run a recall and safety report across every EKL manufacturer
- Watch product code EKL 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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