Manufacturer registered with FDA
Anodia Systems
Danville, KY, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 19
- 510(k) clearances
- 41993–2003
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Devices listed with FDA
What Anodia Systems 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 | C-1310C-1805MC-1890DentaKLEENMAK-1805MAK-1806MAK-1910PRO-KLEENRDH-2000VELOCITY WATER 2 moreWaterlineXZoral Scaler System | 2002 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Cutting Fluid System for Dental High Speed DrillsCUTTING FLUID SYSTEM FOR HIGH SPEED HANDPIECEMint-A-Kleen (MAK-OZ) Dental Unit Waterline CleanerSteri-SolSteri-Sol SystemSteriSOLZoral Scaler Solution | 2003 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Anodia Systems as the applicant.
Also lists devices cleared under other names
Anodia Systems lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Steri-Sol, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Aug 1988 | K882491 | CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS | Steri-Sol, Inc. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ANODIA SYSTEMSFDA reg. 3003917473 | Danville, KY, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9053125). 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.