# K042870: Endo Twinn

- Pathway: 510(k) (Traditional)
- Applicant: Endo Twinn B.V.
- Decided: Jan 11, 2005 after 85 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
Longest line of descent: 1 generation back to K963862 (1996). 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)
- K970715: System B Heat Source, Sybron Dental Specialties, Inc. (1997) Summary page 1.
- K963862: Touch N' Heat, Sybron Dental Specialties, Inc. (1996) Summary page 1.

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

Source page: https://510kreport.com/device/K042870
Methodology: https://510kreport.com/methodology