EBR · Unit, Suction Operatory
Dental · 21 CFR 872.6640 · Class 1
Overview
| Product Code | EBR |
|---|---|
| Device Name | Unit, Suction Operatory |
| Regulation | 21 CFR 872.6640 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Classification Rationale
Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K925367 | A-DEC 7284 CUSPIDOR, CASCADE | A-Dec, Inc. | Apr 11, 1994 | SESE |
| K860058 | DENPAX | Nissho Iwai American Corp. | Mar 12, 1986 | SESE |
| K770600 | OROPHARYNGEAL SUCTION AIRWAY | W.H. Wall, D.D.S. | Apr 8, 1977 | SESE |
Top Applicants
- A-Dec, Inc. — 1 clearance
- Nissho Iwai American Corp. — 1 clearance
- W.H. Wall, D.D.S. — 1 clearance
