FDA product code KJJ: Cleanser, Root Canal
KJJ is the FDA product code for cleanser, root canal. It is a Unclassified device, reviewed by the Dental panel. FDA has cleared 41 510(k) submissions under KJJ, 2 in the last five years, from 26 different applicants. The average 510(k) review took 125 days (median 86); 129 days on average over the last three years. FDA has posted 7 recalls for KJJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Cleanser, Root Canal |
| Device class | Unclassified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for KJJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 201 |
| 2018 | 1 | 133 |
| 2020 | 3 | 249 |
| 2021 | 2 | 252 |
| 2024 | 1 | 106 |
| 2025 | 1 | 152 |
Top KJJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ultradent Products, Inc. | 5 | 2018-02-09 |
| Inter-Med, Inc. | 3 | 2024-08-27 |
| Pac-Dent International, Inc. | 3 | 2016-07-25 |
| Essential Dental Systems, Inc. | 3 | 2014-07-25 |
| Epien Medical, Inc. | 2 | 2021-09-09 |
21 more applicants have KJJ clearances. See the full list in Caduvo.
Most recent KJJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250279 | Belport Company, Inc., Gingi-Pak | RC-SwiftPrep | 2025-07-02 | 152 |
| K241354 | Inter-Med, Inc. | Sealer Solvent | 2024-08-27 | 106 |
| K201785 | Epien Medical, Inc. | EPIEN Dental Cleanser | 2021-09-09 | 436 |
| K211813 | Inter-Med / Vista Dental | Triton | 2021-08-18 | 68 |
| K193357 | Inter-Med/Vista Dental Products | V-Mix | 2020-10-23 | 324 |
Recalls for KJJ devices
7 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-06-27.
| Year | Recalls |
|---|---|
| 2019 | 7 |
Frequently asked questions
What is FDA product code KJJ?
KJJ is the FDA product code for cleanser, root canal. It is a Unclassified device, reviewed by the Dental panel.
What device class is KJJ?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code KJJ?
Across 41 cleared submissions the average was 125 days from receipt to decision (median 86).
Which companies have the most KJJ clearances?
Ultradent Products, Inc. (5); Inter-Med, Inc. (3); Pac-Dent International, Inc. (3); Essential Dental Systems, Inc. (3); Epien Medical, Inc. (2).
Have KJJ devices been recalled?
Yes: 7 product recalls across 1 recall events; the most recent began 2019-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code KJJ
- Run a recall and safety report across every KJJ manufacturer
- Watch product code KJJ 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.