# K041124: Irrigation Tubing Set 2.2M and 3.8M

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Burmoos
- Decided: Jun 7, 2004 after 39 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Irrigation tubings, which were part (accessory) of the submissions of the dental surgical units elcoMED SA-200, elcoMED SA-200 C and implantMED: named in the summary without a submission number

## Most influential descendants
- K090727: Imm Dental Irrigation Tubing Set (2009), 0 descendants of its own

## Indications for use
The irrigation tubing set is an accessory to dental surgical units. The irrigation tubing set is used to supply treatment fluid/coolant liquid from the reservoir to the handpiece via a pump

Source page: https://510kreport.com/device/K041124
Methodology: https://510kreport.com/methodology