# K951607: Sureflex Files

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jun 22, 1995 after 98 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.
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
- K971603: Sterile Sureflex Files and Instruments (1997), 1 descendant of its own
- K082325: Apexum Ablator (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K951607
Methodology: https://510kreport.com/methodology