QYJ · Dental Waterline Treatment Cartridge
Dental · 21 CFR 872.6640 · Class 1
Overview
| Product Code | QYJ |
|---|---|
| Device Name | Dental Waterline Treatment Cartridge |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232393 | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge | Proedge Dental Products, Inc. | Oct 27, 2023 | SESE |
Top Applicants
- Proedge Dental Products, Inc. — 1 clearance
