21 CFR 872.6250 — Chair, Dental, With Operative Unit
Dental (DE) · Subpart G—Miscellaneous Devices · § 872.6250
Identification
A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.
Classification Rationale
Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KLC | Chair, Dental, With Operative Unit | 1 | 63 | 3rd Party |
| NRU | Chair, Dental, Without Operative Unit | 1 | 0 |
