# K971603: Sterile Sureflex Files and Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jun 4, 1997 after 34 days
- Product code: EFA (Handpiece, Belt And/Or Gear Driven, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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 K951607 (1995). 1 ancestor in all.
1 later device descends 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)
- K951607: Sureflex Files, Dentsply Intl. (1995) Summary page 1.

## Most influential descendants
- K082325: Apexum Ablator (2009), 0 descendants of its own

## Indications for use
Used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.

Source page: https://510kreport.com/device/K971603
Methodology: https://510kreport.com/methodology