FDA product code SJH: Portable Dental Operative Unit
SJH is the FDA product code for portable dental operative unit. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under SJH, 1 in the last five years. The average 510(k) review took 269 days (median 269); 269 days on average over the last three years.
Definition
A portable dental operative unit is a device intended to serve as a base station for dental instruments and accessories, delivering utilities such as compressed air, water, suction, and power to handheld dental instruments. The device is designed for use in non-permanent healthcare environments, including dental clinics, hospitals, mobile clinics, long-term care facilities, patient residences, schools, correctional facilities, military or humanitarian field settings, and similar settings, by dental professionals.
Classification
| Field | Value |
|---|---|
| Device name | Portable Dental Operative Unit |
| Device class | Class I |
| Regulation | 21 CFR 872.6640 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for SJH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 269 |
Compare with all 510(k) review times · Search every SJH clearance
Top SJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lakong Medical Devices Co., Ltd. | 1 | 2026-09-10 |
Most recent SJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254009 | Lakong Medical Devices Co., Ltd. | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | 2026-09-10 | 269 |
Recalls for SJH devices
openFDA lists no recalls for product code SJH.
Frequently asked questions
What is FDA product code SJH?
SJH is the FDA product code for portable dental operative unit. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel.
What device class is SJH?
Class I, regulation 21 CFR 872.6640. Typical premarket route: 510(k).
How long does a 510(k) take for product code SJH?
Across 1 cleared submissions the average was 269 days from receipt to decision (median 269).
Which companies have the most SJH clearances?
Lakong Medical Devices Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SJH
- Run a recall and safety report across every SJH manufacturer
- Watch product code SJH 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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