FDA product code EKW: Broach, Endodontic
EKW is the FDA product code for broach, endodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 7 510(k) submissions under EKW, from 7 different applicants. The average 510(k) review took 42 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Broach, Endodontic |
| 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 EKW clearance
Top EKW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Medical, Inc. | 1 | 1987-06-24 |
| Treace Medical, Inc. | 1 | 1987-05-27 |
| Walter Lorenz Surgical, Inc. | 1 | 1986-08-01 |
| Union Branch | 1 | 1983-07-12 |
| Union Broach, Div. Moyco Industries, Inc. | 1 | 1982-12-15 |
2 more applicants have EKW clearances. See the full list in Caduvo.
Most recent EKW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871493 | Advanced Medical, Inc. | DENTI-TRAY(TM) | 1987-06-24 | 69 |
| K870765 | Treace Medical, Inc. | CANNULATED INSTRUMENT CLEANERS | 1987-05-27 | 90 |
| K862523 | Walter Lorenz Surgical, Inc. | MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS | 1986-08-01 | 30 |
| K831749 | Union Branch | ENDODONTIC BROACH(76EKN) BARBED BROACH | 1983-07-12 | 50 |
| K823489 | Union Broach, Div. Moyco Industries, Inc. | ENDODONTIC BROACH-BARBED BROACH | 1982-12-15 | 22 |
Recalls for EKW devices
openFDA lists no recalls for product code EKW.
Frequently asked questions
What is FDA product code EKW?
EKW is the FDA product code for broach, endodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKW?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKW?
Across 7 cleared submissions the average was 42 days from receipt to decision (median 30).
Which companies have the most EKW clearances?
Advanced Medical, Inc. (1); Treace Medical, Inc. (1); Walter Lorenz Surgical, Inc. (1); Union Branch (1); Union Broach, Div. Moyco Industries, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EKW
- Run a recall and safety report across every EKW manufacturer
- Watch product code EKW 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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