FDA product code EJK: Liner, Cavity, Calcium Hydroxide
EJK is the FDA product code for liner, cavity, calcium hydroxide. It is a Class II device, regulated under 21 CFR 872.3250 and reviewed by the Dental panel. FDA has cleared 78 510(k) submissions under EJK, 4 in the last five years, from 50 different applicants. The average 510(k) review took 91 days (median 76); 81 days on average over the last three years. FDA has posted 1 recall for EJK devices.
Classification
| Field | Value |
|---|---|
| Device name | Liner, Cavity, Calcium Hydroxide |
| Device class | Class II |
| Regulation | 21 CFR 872.3250 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EJK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 56 |
| 2019 | 1 | 211 |
| 2020 | 1 | 88 |
| 2021 | 1 | 227 |
| 2022 | 1 | 280 |
| 2023 | 1 | 6 |
| 2026 | 2 | 81 |
Compare with all 510(k) review times · Search every EJK clearance
Top EJK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ultradent Products, Inc. | 5 | 1997-04-02 |
| Bisco, Inc. | 4 | 2018-04-05 |
| Centrix, Inc. | 4 | 2002-07-02 |
| Sybron Dental Specialties, Inc. | 4 | 2001-10-25 |
| Voco GmbH | 4 | 1993-03-31 |
45 more applicants have EJK clearances. See the full list in Caduvo.
Most recent EJK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261728 | Mediclus Co., Ltd. | One-Fil LC | 2026-07-21 | 56 |
| K253248 | Dmp Dental Industry S.A. | Bright Cavity Liner | 2026-01-13 | 106 |
| K230270 | 3M Espe Dental Products | 3M VitCal Liner/Base | 2023-02-06 | 6 |
| K212475 | Prevest Denpro Limited | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | 2022-05-13 | 280 |
| K201799 | Maruchi | CleaniCal | 2021-02-12 | 227 |
Recalls for EJK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-06-05.
Frequently asked questions
What is FDA product code EJK?
EJK is the FDA product code for liner, cavity, calcium hydroxide. It is a Class II device, regulated under 21 CFR 872.3250 and reviewed by the Dental panel.
What device class is EJK?
Class II, regulation 21 CFR 872.3250. Typical premarket route: 510(k).
How long does a 510(k) take for product code EJK?
Across 78 cleared submissions the average was 91 days from receipt to decision (median 76).
Which companies have the most EJK clearances?
Ultradent Products, Inc. (5); Bisco, Inc. (4); Centrix, Inc. (4); Sybron Dental Specialties, Inc. (4); Voco GmbH (4).
Have EJK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-06-05.
Next steps
- Run an FDA pathway report with predicate devices for product code EJK
- Run a recall and safety report across every EJK manufacturer
- Watch product code EJK 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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