Data / Medical devices / United States / Anodia Systems
Anodia Systems: FDA-registered device maker in Danville, KY, United States, 5 510(k) clearances
Anodia Systems is registered with the FDA (registration 3003917473) in Danville, KY, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 19, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003917473
- Address
- 109 Larrimore Lane, Danville, KY, United States, 40422
- Owner or operator
- ANODIA SYSTEMS, LLC (9053125)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 19, 2002
- Registered through
- 2026
- Brand names listed
- C-1310, C-1805M, C-1890, CUTTING FLUID SYSTEM FOR HIGH SPEED HANDPIECE, Cutting Fluid System for Dental High Speed Drills, DentaKLEEN, MAK-1805, MAK-1806 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer, Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 19, 2003 | K023896 | C-1890 | EIA | Substantially Equivalent | Anodia Systems | accessdata.fda.gov |
| June 19, 2003 | K023815 | C-1805M | EIA | Substantially Equivalent | Anodia Systems | accessdata.fda.gov |
| January 16, 2003 | K023213 | RDH-2000 | EIA | Substantially Equivalent | Anodia Systems | accessdata.fda.gov |
| July 22, 1993 | K925378 | STERI-SOL SOLUTION, MODIFICATION | EFB | Substantially Equivalent | Anodia Systems | accessdata.fda.gov |
| August 26, 1988 | K882491 | CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS | EFB | Substantially Equivalent | Steri-Sol, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 19, 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.