# K070246: Down Pak

- Pathway: 510(k) (Special)
- Applicant: Endo Twinn B.V.
- Decided: Feb 16, 2007 after 22 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 FDA summary names its predicate without a number.
- (no number) Endo Twinn: named in the summary without a submission number

## Indications for use
The intended use of the dental instrument heater - The Down Pak - is to provide continuous heat and/or vibration at the tip of a dental instrument. The Down Pak is designed for processing gutta percha (cutting softening, spreading, compacting) and cutting plastic handles of obturators during :Iroot canal treatment. The device may only be operated by dentists; and endodontists.

Source page: https://510kreport.com/device/K070246
Methodology: https://510kreport.com/methodology