# K042828: Obtura Gutta Percha Delivery System, Model 823-700

- Pathway: 510(k) (Abbreviated)
- Applicant: Young O/S, LLC
- Decided: Dec 1, 2004 after 50 days
- Product code: EKR (Plugger, Root Canal, Endodontic)
- Device class: 1
- Regulation: 21 CFR 872.4565
- 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 K832654 (1983). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832654: Heated Gutta Percha Delivery System, Unitek Corp. (1983) Summary page 1.
- K031664: Elements Obturation Unit, Sybron Endo/Analytic (2004) Summary page 1.

## Most influential descendants
- K060347: B&L L-Beta, Model WL-B1 (2006), 0 descendants of its own

## Indications for use
The Obtura is intended for use by professionally qualified Licensed dentists, endodontists and clinicians to heat gutta percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.

Source page: https://510kreport.com/device/K042828
Methodology: https://510kreport.com/methodology