NRD · Unit, Operative Dental, Accessories
Dental · 21 CFR 872.6640 · Class 1
Overview
| Product Code | NRD |
|---|---|
| Device Name | Unit, Operative Dental, Accessories |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K072273 | BELMONT QUOLIS 5000 SERIES DENTAL UNIT | Takara Belmont USA, Inc. | Dec 20, 2007 | SESE |
| K042266 | ACCLAIM | Air Techniques, Inc. | Aug 31, 2004 | SESE |
Top Applicants
- Air Techniques, Inc. — 1 clearance
- Takara Belmont USA, Inc. — 1 clearance
