K232393 is an FDA 510(k) clearance for the BluTube® Dental Unit Water Purification Cartridge (BluTube®). This device is classified as a Dental Waterline Treatment Cartridge (Class I - General Controls, product code QYJ).
Submitted by Proedge Dental Products, Inc. (Centennial, US). The FDA issued a Cleared decision on October 27, 2023, 79 days after receiving the submission on August 9, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640. Intended To Reduce Microbial Bioburden In Dental Unit Water Lines.
| 510(k) Number | K232393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2023 |
| Decision Date | October 27, 2023 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | QYJ - Dental Waterline Treatment Cartridge |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |
| Definition | Intended To Reduce Microbial Bioburden In Dental Unit Water Lines |