Manufacturer registered with FDA
iLumi Sciences inc
Chantilly, VA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 535 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name iLumi Sciences 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 | iLumi Sciences inc | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | iLumi Sciences, Inc. | 32 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | iLumi Sciences, Inc | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ILUMI SCIENCES, INC. | 1 | 2013–2013 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | iLumi Sciences Inc. | 1 | — | 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 iLumi Sciences 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 |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Dental Fiber Post Drill | 2012 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Dental Fiber Post (U-Post, X-Post, E-Post) | 2012 |
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 |
|---|---|---|
| ILUMI SCIENCES INCFDA reg. 3009850967 | Chantilly, VA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042411). 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.