FDA product code EKR: Plugger, Root Canal, Endodontic
EKR is the FDA product code for plugger, root 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 EKR, from 6 different applicants. The average 510(k) review took 109 days (median 56). FDA has posted 3 recalls for EKR devices.
Classification
| Field | Value |
|---|---|
| Device name | Plugger, Root 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 EKR clearance
Top EKR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| B&L Biotech Co., Ltd. | 1 | 2006-06-05 |
| Young O/S, LLC | 1 | 2004-12-01 |
| Sybron Endo/Analytic | 1 | 2004-04-28 |
| Dentsply Intl. | 1 | 1986-03-26 |
| Union Branch | 1 | 1983-07-12 |
1 more applicants have EKR clearances. See the full list in Caduvo.
Most recent EKR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060347 | B&L Biotech Co., Ltd. | B&L L-BETA, MODEL WL-B1 | 2006-06-05 | 115 |
| K042828 | Young O/S, LLC | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | 2004-12-01 | 50 |
| K031664 | Sybron Endo/Analytic | ELEMENTS OBTURATION UNIT | 2004-04-28 | 335 |
| K860569 | Dentsply Intl. | ENDODONTIC ROOT CANAL PLUGGER | 1986-03-26 | 43 |
| K831748 | Union Branch | ENDODONTIC ROOT CANAL PLUGGER FINGER- | 1983-07-12 | 50 |
Recalls for EKR devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-27.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code EKR?
EKR is the FDA product code for plugger, root canal, endodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKR?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKR?
Across 6 cleared submissions the average was 109 days from receipt to decision (median 56).
Which companies have the most EKR clearances?
B&L Biotech Co., Ltd. (1); Young O/S, LLC (1); Sybron Endo/Analytic (1); Dentsply Intl. (1); Union Branch (1).
Have EKR devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2017-12-27.
Next steps
- Run an FDA pathway report with predicate devices for product code EKR
- Run a recall and safety report across every EKR manufacturer
- Watch product code EKR 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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