# K943584: Presterilized Endodontic Files

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Sep 21, 1994 after 61 days
- Product code: EKJ (Burnisher, Operative)
- 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
No predicates in its family tree.
251 later devices descend from it; 2 cite it directly.
0 of 252 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
- K962031: Quantec Series 2000 Endodontic Files (1996), 249 descendants of its own
- K012511: Waterlase Millennium (2002), 246 descendants of its own
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own

Source page: https://510kreport.com/device/K943584
Methodology: https://510kreport.com/methodology