Data / Medical devices / United States / Sterisil
Sterisil: FDA-registered device maker in Colorado Spgs, CO, United States, 1 510(k) clearance
Sterisil is registered with the FDA (registration 3005844469) in Colorado Spgs, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 30, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005844469
- Address
- 4220 Mark Dabling Blvd, Colorado Spgs, CO, United States, 80907
- Owner or operator
- Solmetex (Sterisil) (9090239)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 26, 2006
- Registered through
- 2026
- Brand names listed
- STERISIL ANTIMICROBIAL TUBING AND BOTTLE, Sterisil® Dental Water Microbiological Cartridge - Stage 5, Sterisil® Dental Water Microbiological Inline Cartridge, Sterisil® Dental Water Microbiological Valved Cartridge, Sterisil® Straw
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dental Waterline Treatment Cartridge | QYJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 30, 2003 | K031681 | STERISIL ANTIMICROBIAL TUBING AND BOTTLE | EIA | Substantially Equivalent | Sterisil | accessdata.fda.gov |
Compare with other makers
Updated October 30, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.