# K971319: NT Series Endodontic Files, Mac Series Endodontic Files

- Pathway: 510(k) (Traditional)
- Applicant: Tycom Dental
- Decided: May 22, 1997 after 42 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
Longest line of descent: 2 generations back to K933582 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962031: Quantec Series 2000 Endodontic Files, Tycom Dental (1996) Summary page 2.

## Indications for use
The NT and Mac Series Endodontic Files are engine files and hand instruments designed for use in root canal preparation.

Source page: https://510kreport.com/device/K971319
Methodology: https://510kreport.com/methodology