Dental Waterline Treatment Cartridge
The dental waterline treatment cartridge (product code QYJ) is a Class 1 Dental device (regulation 872.6640) intended to reduce microbial bioburden in dental unit water lines. As a Class 1 device subject to general controls only, it is GMP-exempt and requires no 510(k) submission, relying instead on De Novo or exemption pathways. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QYJ
- Device Class
- FDA class 1
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
Definition
Intended to reduce microbial bioburden in dental unit water lines
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232393 | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge | Oct 27, 2023 | Substantially Equivalent | Proedge Dental Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.