Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003917473

FEI Number

3003917473

Entity Name

ANODIA SYSTEMS

City/State/Country

Danville, KY, US

Establishment Address

109 LARRIMORE LANE, Danville, KY 40422, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

ANODIA SYSTEMS, LLC (Owner Number: 9053125)

Owner / Operator Contact Address

109 LARRIMORE LANE, --, Danville, KY 40422, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K882491

PMA Number

N/A

All Registered Proprietary Names

C-1890 WaterlineX MAK-1806 CUTTING FLUID SYSTEM FOR HIGH SPEED HANDPIECE Zoral Scaler Solution Mint-A-Kleen (MAK-OZ) Dental Unit Waterline Cleaner Steri-Sol SteriSOL C-1805M DentaKLEEN MAK-1805 VELOCITY WATER PRO-KLEEN MAK-1910 RDH-2000 C-1310 Zoral Scaler System Cutting Fluid System for Dental High Speed Drills Steri-Sol SteriSOL Steri-Sol System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2002-11-19
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2003-05-21
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2002-11-19
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2002-11-19
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2018-08-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ANODIA SYSTEMS, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003917473. Last updated year: 2026. Please use registration number 3003917473 when referencing this establishment in official correspondence.