Manufacturer registered with FDA
Led Dental, Inc.
Vancouver, Canada. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 22007–2010
- Markets registered in
- 716 registrations outside the US
- Establishments
- 1Canada
510(k) clearances per year, 2000–2026
Registered in 7 markets
Where regulators' registries name Led Dental, 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 | Led Dental, Inc. | 2 clearances | 2007–2010 | Below |
| Canada | Health Canada | Registration holder | LED DENTAL INC. | 9 | 2006–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | LED Dental Inc.LED Dental Inc | 3 | 2007–2016 | Pure Global AI |
| Australia | TGA | Manufacturer | LED Dental Inc | 1 | 2020–2020 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | LED DENTAL INC. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | LED Dental Inc. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | LED DENTAL INC. | 1 | 2008–2008 | 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 Led Dental, 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 |
|---|---|---|---|---|
| Soft Tissue Detector Diagnostic LightNXV · Class 2 | — | Maker | VELscope Vx | 2010 |
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 |
|---|---|---|
| LED DENTAL INC.FDA reg. 3005374252 | Vancouver British Columbia, Canada | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9077785). 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.