SJH — Portable Dental Operative Unit Class I
FDA product code SJH covers "Portable Dental Operative Unit", a Class I medical device regulated under 21 CFR 872.6640. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SJH
- Device Class
- Class I
- Regulation Number
- 872.6640
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254009 | Lakong Medical Devices Co | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Sep 10, 2026 |