Data / Medical devices / United States / Proedge Dental Products
Proedge Dental Products: FDA-registered device maker in Centennial, CO, United States, 1 510(k) clearance
Proedge Dental Products is registered with the FDA (registration 3009161303) in Centennial, CO, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 27, 2023. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009161303
- Address
- 10730 E Briarwood Ave, Centennial, CO, United States, 80112
- Owner or operator
- ProEdge Dental Products (9045179)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- September 1, 2006
- Registered through
- 2027
- Brand names listed
- BluTab Waterline Maintenance Tablets, BluTube, BluTube Dental Unit Water Purification Cartridge, SoftX Foam Digital Sensor Loops
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dental Waterline Treatment Cartridge | QYJ | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Specification developer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 27, 2023 | K232393 | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge | QYJ | Substantially Equivalent | Proedge Dental Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental
- All makers of Unit, Operative Dental, Accessories
- All makers of Holder, Film, X-Ray
Updated October 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.