BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge
FDA 510(k) clearance K232393 · decided 2023-10-27
Clearance details
- K-number
- K232393
- Device name
- BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge
- Applicant
- Proedge Dental Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-09
- Decision date
- 2023-10-27
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- QYJ
- Device class
- 1
- Regulation number
- 872.6640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Centennial, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.