# K062856: TF Rotary Nickel Titanium File

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Dec 13, 2006 after 79 days
- Product code: EKS (File, Pulp 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sybron Endo, Quantec Series 2000 Endodontic File: named in the summary without a submission number

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

## Indications for use
The TF Rotary Nickel Titanium File is a rotary endodontic file designed for use in root canal preparation.

Source page: https://510kreport.com/device/K062856
Methodology: https://510kreport.com/methodology