FDA product code QYJ: Dental Waterline Treatment Cartridge
QYJ is the FDA product code for dental waterline treatment cartridge. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under QYJ, 1 in the last five years. The average 510(k) review took 79 days (median 79).
Definition
Intended to reduce microbial bioburden in dental unit water lines
Classification
| Field | Value |
|---|---|
| Device name | Dental Waterline Treatment Cartridge |
| Device class | Class I |
| Regulation | 21 CFR 872.6640 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QYJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 79 |
Compare with all 510(k) review times · Search every QYJ clearance
Top QYJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Proedge Dental Products, Inc. | 1 | 2023-10-27 |
Most recent QYJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232393 | Proedge Dental Products, Inc. | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge | 2023-10-27 | 79 |
Recalls for QYJ devices
openFDA lists no recalls for product code QYJ.
Frequently asked questions
What is FDA product code QYJ?
QYJ is the FDA product code for dental waterline treatment cartridge. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel.
What device class is QYJ?
Class I, regulation 21 CFR 872.6640. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QYJ?
Across 1 cleared submissions the average was 79 days from receipt to decision (median 79).
Which companies have the most QYJ clearances?
Proedge Dental Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QYJ
- Run a recall and safety report across every QYJ manufacturer
- Watch product code QYJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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