21 CFR 872.6640 — Mouthpiece, Saliva Ejector
Dental (DE) · Subpart G—Miscellaneous Devices · § 872.6640
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DYN | Mouthpiece, Saliva Ejector | 1 | 18 | |
| EBR | Unit, Suction Operatory | 1 | 3 | |
| EHZ | Evacuator, Oral Cavity | 1 | 17 | |
| EIA | Unit, Operative Dental | 1 | 284 | 3rd Party |
| NRD | Unit, Operative Dental, Accessories | 1 | 2 | |
| OFX | General Purpose Dental Tray | 1 | 0 | |
| QYJ | Dental Waterline Treatment Cartridge | 1 | 1 |
