FDA product code EKP: Reamer, Pulp Canal, Endodontic
EKP is the FDA product code for reamer, pulp canal, endodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 6 510(k) submissions under EKP, from 6 different applicants. The average 510(k) review took 22 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Reamer, Pulp Canal, 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 EKP clearance
Top EKP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United Dental Mfg., Inc. | 1 | 1982-12-28 |
| Union Broach, Div. Moyco Industries, Inc. | 1 | 1982-09-28 |
| Ipco Corp. | 1 | 1980-02-19 |
| Janneck Ent. of Texas | 1 | 1977-04-20 |
| Ransom and Randolph | 1 | 1977-04-05 |
1 more applicants have EKP clearances. See the full list in Caduvo.
Most recent EKP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823686 | United Dental Mfg., Inc. | REAMER TYPE K ENDODONTIC | 1982-12-28 | 21 |
| K822620 | Union Broach, Div. Moyco Industries, Inc. | ROOT CANAL REAMERS, TYPE K | 1982-09-28 | 29 |
| K800291 | Ipco Corp. | ENDEX REAMERS PULP CANAL, ENDODONTIC | 1980-02-19 | 8 |
| K770331 | Janneck Ent. of Texas | DIALYSIS, JET SYSTEM | 1977-04-20 | 62 |
| K770598 | Ransom and Randolph | ENDODONTIC INSTRUMENTS, R&R CUTWELL | 1977-04-05 | 7 |
Recalls for EKP devices
openFDA lists no recalls for product code EKP.
Frequently asked questions
What is FDA product code EKP?
EKP is the FDA product code for reamer, pulp canal, endodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKP?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKP?
Across 6 cleared submissions the average was 22 days from receipt to decision (median 14).
Which companies have the most EKP clearances?
United Dental Mfg., Inc. (1); Union Broach, Div. Moyco Industries, Inc. (1); Ipco Corp. (1); Janneck Ent. of Texas (1); Ransom and Randolph (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EKP
- Run a recall and safety report across every EKP manufacturer
- Watch product code EKP 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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