Miscellaneous devices · 21 CFR 872 Subpart G
Portable Dental Operative Unit
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.
- Companies listing it
- 21 makers
- Brands and models
- 9
- 510(k) clearances
- 11 in five years
- FDA name
- Portable Dental Operative Unit
510(k) clearances per year, 1976–2026
Companies that list SJH
2 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Lakong Medical Devices Co., Ltd. | China | Maker | Portable Dental Unit, PC2630, OMC2375CV, MC3600CV | 2 | 2026 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | MC3600CV Mirage Mobile Cart · MC3600CVSL Mirage Mobile Cart · OMC2375CV Mobile Orthodontic Cabinet w Unit · OMC2375CVSL Orthodontic Mobile Cabinet w Unit · +4 | 3 | 2007 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 10 Sep 2026 | K254009 | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Lakong Medical Devices Co., Ltd. |
Official records: FDA product classification for SJH · 21 CFR 872.6640.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026