510(k) · Cleared

Cleared

NT Series Endodontic Files, Mac Series Endodontic Files

K971319510(k) TraditionalCleared May 22, 199742-day reviewClass I21 CFR 872.4565

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tycom Dental · EKS File, Pulp Canal, Endodontic

Cleared on May 22, 1997 as substantially equivalent to K962031 (Tycom Dental, 1996) after a 42-day review. Its family tree reaches back 2 generations to 1993.

Decided: May 22, 1997
Review: 42 days
Class: Class I
Product code: EKS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K933582 (1993). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK933582 Profile Series 29 FilesTulsa Dental Products, Ltd. · 1993
1 generation backK962031 Quantec Series 2000 Endodontic FilesTycom Dental · 1996
This deviceK971319 NT Series Endodontic Files, Mac Series Endodontic FilesTycom Dental · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K933582	Profile Series 29 Files	Tulsa Dental Products, Ltd.	1993	—
−1	K962031	Quantec Series 2000 Endodontic Files	Tycom Dental	1996	—
0 (this device)	K971319	NT Series Endodontic Files, Mac Series Endodontic Files	Tycom Dental	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K971319, 1993–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EKS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K962031	Quantec Series 2000 Endodontic Files Summary page 2 …iles b. Classification Name(s): Pulp Canal, Endodontic File IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Tycom Dental Quantec Series 2000 K962031 June 4, 1996 15.4 15.5 15.6 15.7 DEVICE DESCRIPTION The NT and Mac Series Endodontic Files are a series of e…	Tycom Dental	1996	—

Also cleared against K962031: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K962031.

How does its category compare?

All EKS devices

EKS File, Pulp Canal, Endodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKS

FDA has decided no EKS device since 2007.

Median 510(k) review, days · EKS

Too few EKS 510(k)s in any year since 2007 to give a median.

Recalls per year · EKS

1in 2012

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EKS

324in 2025

2007high 468 (2019) · low 10 (2008)2025

MAUDE reports naming product code EKS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	104
2008	—	1	10
2009	—	0	16
2010	—	0	10
2011	—	0	20
2012	—	1	14
2013	—	0	30
2014	—	0	17
2015	—	0	56
2016	—	0	28
2017	—	0	53
2018	—	0	258
2019	—	0	468
2020	—	0	421
2021	—	0	342
2022	—	0	291
2023	—	0	264
2024	—	0	313
2025	—	0	324
2026	—	0	—

What is it indicated for?

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971319 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971319: NT Series Endodontic Files, Mac Series Endodontic Files.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971319

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026