FDA product code EKN: Point, Paper, Endodontic
EKN is the FDA product code for point, paper, endodontic. It is a Class I device, regulated under 21 CFR 872.3830 and reviewed by the Dental panel. FDA has cleared 7 510(k) submissions under EKN, from 6 different applicants. The average 510(k) review took 39 days (median 22). FDA has posted 5 recalls for EKN devices.
Classification
| Field | Value |
|---|---|
| Device name | Point, Paper, Endodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.3830 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EKN clearance
Top EKN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United Dental Mfg., Inc. | 2 | 1985-01-09 |
| Roeko | 1 | 1982-06-14 |
| Premier Dental Products Co. | 1 | 1980-04-29 |
| Ransom and Randolph | 1 | 1978-10-10 |
| Johnson & Johnson Professionals, Inc. | 1 | 1976-12-13 |
1 more applicants have EKN clearances. See the full list in Caduvo.
Most recent EKN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843017 | United Dental Mfg., Inc. | ABSORBENT ENDODONTIC POINT | 1985-01-09 | 162 |
| K821625 | Roeko | ENDODONTIC PAPERPOINTS | 1982-06-14 | 12 |
| K812886 | United Dental Mfg., Inc. | ENDODONTIC PAPER POINTS | 1981-11-16 | 33 |
| K800827 | Premier Dental Products Co. | PREMIER ABSORBENT POINTS | 1980-04-29 | 15 |
| K781605 | Ransom and Randolph | R&R ABSORBENT POINTS | 1978-10-10 | 22 |
Recalls for EKN devices
5 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-08-04.
| Year | Recalls |
|---|---|
| 2017 | 5 |
Frequently asked questions
What is FDA product code EKN?
EKN is the FDA product code for point, paper, endodontic. It is a Class I device, regulated under 21 CFR 872.3830 and reviewed by the Dental panel.
What device class is EKN?
Class I, regulation 21 CFR 872.3830. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKN?
Across 7 cleared submissions the average was 39 days from receipt to decision (median 22).
Which companies have the most EKN clearances?
United Dental Mfg., Inc. (2); Roeko (1); Premier Dental Products Co. (1); Ransom and Randolph (1); Johnson & Johnson Professionals, Inc. (1).
Have EKN devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2017-08-04.
Next steps
- Run an FDA pathway report with predicate devices for product code EKN
- Run a recall and safety report across every EKN manufacturer
- Watch product code EKN 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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