QYJ — Dental Waterline Treatment Cartridge Class I
FDA product code QYJ covers "Dental Waterline Treatment Cartridge", a Class I medical device regulated under 21 CFR 872.6640. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QYJ
- Device Class
- Class I
- Regulation Number
- 872.6640
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
Intended to reduce microbial bioburden in dental unit water lines
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232393 | proedge dental products | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB1 | October 27, 2023 |