# K073369: EI Downpak Barrier Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Hu-Friedy Mfg. Co., Inc.
- Decided: Feb 27, 2008 after 89 days
- Product code: EKM (Gutta-Percha)
- Device class: 1
- Regulation: 21 CFR 872.3850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K983406: Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths for, Banta Healthcare Group, Ltd. (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
This product is intended for use by dental professionals only. This device is an accessory to the El DownPak Endodontic Obturator Handpiece which is used in the oral cavity for root canal therapy. The barrier sleeve will be used to cover the hand piece thereby reducing the risk of cross infection while in use.

Source page: https://510kreport.com/device/K073369
Methodology: https://510kreport.com/methodology