FDA product code JEQ: Toothbrush, Powered
JEQ is the FDA product code for toothbrush, powered. It is a Class I device, regulated under 21 CFR 872.6865 and reviewed by the Dental panel. FDA has cleared 54 510(k) submissions under JEQ, from 48 different applicants. The average 510(k) review took 104 days (median 90). FDA has posted 36 recalls for JEQ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Toothbrush, Powered |
| Device class | Class I |
| Regulation | 21 CFR 872.6865 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
510(k) clearances per year for JEQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 147 |
Compare with all 510(k) review times · Search every JEQ clearance
Top JEQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Dentronics, Inc. | 3 | 1994-05-18 |
| Braun GmbH | 2 | 2006-06-05 |
| John O. Butler Co. | 2 | 2002-11-14 |
| Bausch & Lomb, Inc. | 2 | 1994-01-26 |
| Omron Healthcare, Inc. | 2 | 1993-04-14 |
43 more applicants have JEQ clearances. See the full list in Caduvo.
Most recent JEQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200881 | The Procter & Gamble Company | Oral-B iO Test Drive Power Brush Trial Program Kit | 2020-08-27 | 147 |
| K141018 | Procter & Gamble Co. | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT | 2014-09-15 | 147 |
| K061351 | Braun GmbH | ORAL-B SONIC COMPLETE | 2006-06-05 | 21 |
| K061199 | Braun GmbH | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | 2006-05-31 | 33 |
| K040416 | Philips Oral Healthcare, Inc. | SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 | 2004-07-02 | 135 |
Recalls for JEQ devices
36 product recalls in 9 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-05-21.
| Year | Recalls |
|---|---|
| 2026 | 2 |
Frequently asked questions
What is FDA product code JEQ?
JEQ is the FDA product code for toothbrush, powered. It is a Class I device, regulated under 21 CFR 872.6865 and reviewed by the Dental panel.
What device class is JEQ?
Class I, regulation 21 CFR 872.6865. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JEQ?
Across 54 cleared submissions the average was 104 days from receipt to decision (median 90).
Which companies have the most JEQ clearances?
American Dentronics, Inc. (3); Braun GmbH (2); John O. Butler Co. (2); Bausch & Lomb, Inc. (2); Omron Healthcare, Inc. (2).
Have JEQ devices been recalled?
Yes: 36 product recalls across 9 recall events; the most recent began 2026-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code JEQ
- Run a recall and safety report across every JEQ manufacturer
- Watch product code JEQ 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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