Manufacturer registered with FDA
Solmetex (Sterisil)
Colorado Springs, CO, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 12003–2003
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Solmetex (Sterisil) 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 | Solmetex (Sterisil) | 1 clearances | 2003–2003 | Below |
| United Kingdom | MHRA | Manufacturer | Sterisil, 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 Solmetex (Sterisil) currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | STERISIL ANTIMICROBIAL TUBING AND BOTTLE | 2006 |
| Dental Waterline Treatment CartridgeQYJ · Class 1 | — | Maker | Sterisil® Dental Water Microbiological Inline CartridgeSterisil® Dental Water Microbiological Valved CartridgeSterisil® Dental Water Microbiological Cartridge - Stage 5Sterisil® Straw | 2024 |
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 |
|---|---|---|
| SterisilFDA reg. 3005844469 | Colorado Spgs, CO, United States | Manufacturer, Repacker / relabeler |
Other names on FDA records
Sterisil, Inc
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9090239). 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.