QYJ
- Product code
- QYJ
- Device name
- Dental Waterline Treatment Cartridge
- Device class
- Class 1
- 21 CFR
- 21 CFR 872.6640
- Medical specialty
- Dental
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
Intended to reduce microbial bioburden in dental unit water lines
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232393 | 2023-10-27 | Proedge Dental Products, Inc. | BluTube® Dental Unit Water Purification Cartridge (B… |
Official FDA classification page: QYJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).