DeviceClearance

Product code SJH— Dental

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

Classification name
Portable Dental Operative Unit
Device class
Class 1
Regulation
21 CFR 872.6640
Advisory panel
Dental
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SJH under 21 CFR 872.6640, via openFDA

Market context for product code SJH

FDA has cleared 1 device under product code SJH, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code SJH

Recent clearances under product code SJH

Data sourced from openFDA. This site is unofficial and independent of the FDA.