# K832654: Heated Gutta Percha Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Unitek Corp.
- Decided: Sep 26, 1983 after 49 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042828: Obtura Gutta Percha Delivery System, Model 823-700 (2004), 1 descendant of its own
- K060347: B&L L-Beta, Model WL-B1 (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K832654
Methodology: https://510kreport.com/methodology