Manufacturer registered with FDA
ProEdge Dental Products
Centennial, CO, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 5
- 510(k) clearances
- 12023–2023
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What ProEdge Dental Products currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| X-Ray Film HolderEGZ · Class 1 | — | Maker | SoftX Foam Digital Sensor Loops | 2009 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | BluTube | 2024 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | BluTab Waterline Maintenance TabletsBluTube Dental Unit Water Purification Cartridge | 2006 |
| Dental Waterline Treatment CartridgeQYJ · Class 1 | — | Maker | BluTube | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names ProEdge Dental Products as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PROEDGE DENTAL PRODUCTSFDA reg. 3009161303 | Centennial, CO, United States | Contract manufacturer, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9045179). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.