Manufacturer registered with FDA
Denbur Inc
Westmont, IL, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 510 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Denbur Inc as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Denbur Inc | 4 device types | — | Below |
| South Korea | MFDS | Manufacturer | Denbur, Inc.DENBUR, INC. · Denbur, Inc | 4 | 2001–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENBUR, INC | 4 | 2014–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | Denbur Inc | 1 | 2018–2018 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENBUR, INC. | 1 | 2006–2006 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Denbur Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Fiber Optic LightEAY · Class 1 | Dental operating lights | Maker | Light-Tip | 2007 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | C-Flow, EZ-Flow, Den-Flow | 2007 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Fracfinder | 2007 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Multi-Brush Original Blue, Multi-Brush Multi-Colors, Magic-Brush, Nano-Brush, Maxi-Brush, Master-Brush, VO-Brush | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENBUR, INC.FDA reg. 3006264569 | WESTMONT, IL, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1450526). 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.