510(k) K232393
- Device
- 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.
- 510(k) number
- K232393
- Product code
- QYJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-27
- Date received
- 2023-08-09
- Regulation
- 872.6640
- Classification name
- Dental Waterline Treatment Cartridge
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Mark Frampton
- Address
- 7042 S. Revere Pkwy., Suite 400 Centennial CO US 80112 80112
FDA Registration Numbers
- 3009161303
- 3015729
- 3005844469