Miscellaneous devices · 21 CFR 872 Subpart G
Dental Waterline Treatment Cartridge
Intended to reduce microbial bioburden in dental unit water lines
- Companies listing it
- 32 makers
- Brands and models
- 6
- 510(k) clearances
- 11 in five years
- FDA name
- Dental Waterline Treatment Cartridge
510(k) clearances per year, 1976–2026
Companies that list QYJ
3 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| ProEdge Dental Products | United States | Maker | BluTube | 1 | 2023 |
| Solmetex (Sterisil) | United States | Maker | Sterisil® Dental Water Microbiological Inline Cartridge · Sterisil® Dental Water Microbiological Valved Cartridge · Sterisil® Dental Water Microbiological Cartridge - Stage 5 · Sterisil® Straw | 1 | 2003 |
| A-dec, Inc. | United States | Manufacturer | A-dec Maintain | 68 | 2022 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 27 Oct 2023 | K232393 | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge | ProEdge Dental Products |
Official records: FDA product classification for QYJ · 21 CFR 872.6640.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026