Product code QYJ
- Device name
- Dental Waterline Treatment Cartridge
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6640
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Intended to reduce microbial bioburden in dental unit water lines
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K232393 | BluTubeĀ® Dental Unit Water Purification Cartridge (BluTubeĀ®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge | Proedge Dental Products, Inc. | 2023-10-27 |