4631 DUO DELIVERY SYSTEM
Device Facts
| Record ID | K000966 |
|---|---|
| Device Name | 4631 DUO DELIVERY SYSTEM |
| Applicant | A-Dec, Inc. |
| Product Code | EIA · Dental |
| Decision Date | May 3, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6640 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.
