| Device |
portable dental operative unit |
| Regulation Description |
Dental operative unit and accessories. |
| 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. |
| Physical State |
A portable unit consisting of a main housing that integrates or connects to a compressed air source, water supply, handpiece tubing, and operator controls, and may include a suction system. The housing may take the form of a compact case, cabinet, or trolley-style enclosure with handles, grips, or carrying straps. Components and accessories may be detachable for disassembly and storage. |
| Technical Method |
Delivers compressed air, water, and suction to connected dental handpieces and instruments via handpiece tubing using a compressed air source, water supply, and suction system. Control of the air and water flow is achieved via valves and operator controls such as a footswitch. The device may be powered by an external AC electrical source, battery, or other power supply. |
| Target Area |
Oral cavity / mouth |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | SJH |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
872.6640
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
