# K971606: Sterile Flexofile Files and Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jun 3, 1997 after 33 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 K943584 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943584: Presterilized Endodontic Files, Dentsply Intl. (1994) Summary page 1.

## 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/K971606
Methodology: https://510kreport.com/methodology