# K023213: RDH-2000

- Pathway: 510(k) (Traditional)
- Applicant: Anodia Systems
- Decided: Jan 16, 2003 after 112 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K882491 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882491: Cutting Fluid System for Dental High Speed Drills, Steri-Sol, Inc. (1988) Summary page 1.
- K962665: A-Dec Self-Contained Water System, A-Dec, Inc. (1996) Summary page 1.

## Indications for use
Portable pressurized system to deliver a solution to a scalar. Scalar being a dental device powered by air or electricity to remove tartar from the teeth requiring a solution for its performance.

Source page: https://510kreport.com/device/K023213
Methodology: https://510kreport.com/methodology