510(k) · Cleared

Cleared

Quantec Series 2000 Endodontic Files

K962031510(k) TraditionalCleared Jun 4, 199611-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 Jun 4, 1996 as substantially equivalent to K933582 (Tulsa Dental Products, Ltd., 1993) and 1 other predicate after an 11-day review. Its family tree reaches back 1 generation to 1993. 249 later devices descend from it.

Decided: Jun 4, 1996
Review: 11 days
Class: Class I
Product code: EKS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K933582 (1993). 2 ancestors in all. 249 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK933582 Profile Series 29 FilesTulsa Dental Products, Ltd. · 1993
This deviceK962031 Quantec Series 2000 Endodontic FilesTycom Dental · 1996
Descendant · cites it directly · 246 of its ownK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
Descendant · 2 generations on · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
Descendant · 3 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
Descendant · 4 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Descendant · 5 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008

Showing 5 of 249 descendants. See all descendants

Descendants cleared per year

1997high 29 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 249 · See all

K012511Waterlase MillenniumBiolase Technology, Inc. · 2002 · cites it directly246descendants
K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · 2 generations on240descendants
K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 3 generations on226descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 4 generations on221descendants
K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 5 generations on202descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933582	Profile Series 29 Files	Tulsa Dental Products, Ltd.	1993	—
0 (this device)	K962031	Quantec Series 2000 Endodontic Files	Tycom Dental	1996	—
+1	K012511	Waterlase Millennium	Biolase Technology, Inc.	2002	—
+2	K021508	Opusduo EC Dental Laser System	Opusdent, Ltd.	2002	—
+3	K040270	Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum	Lumenis, Ltd.	2004	—
+4	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—
+5	K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	2	0
2004	2	0
2006	3	0
2007	4	0
2008	11	0
2009	5	0
2010	10	0
2011	7	0
2012	4	0
2013	10	0
2014	11	0
2015	12	0
2016	10	0
2017	7	0
2018	13	0
2019	7	0
2020	14	0
2021	10	0
2022	24	0
2023	14	0
2024	24	0
2025	29	0
2026	15	0

FIG. 1 — Lineage of K962031, 1993–2026Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K933582	Profile Series 29 Files Summary page 1 …n Name(s): IntraOral Dental Drill Dental Hand Instrument 15.3 IDENTIFICATION OF PREDICATE DEVICE Company Device S10(k) No, Date Cleared Tulsa Dental Profile 29 Series K933582 10/20/93 Dentsply SureFlex Endodontic K943584 09/21/94 Files nNnnnnoa 154 15.5 15.6 15.7 158 DEVICE DESCRI…	Tulsa Dental Products, Ltd.	1993	—
*	K943584	Presterilized Endodontic Files Summary page 1 …nstrument 15.3 IDENTIFICATION OF PREDICATE DEVICE Company Device S10(k) No, Date Cleared Tulsa Dental Profile 29 Series K933582 10/20/93 Dentsply SureFlex Endodontic K943584 09/21/94 Files nNnnnnoa 154 15.5 15.6 15.7 158 DEVICE DESCRIPTION The Quantec Series 2000 Endodontic Files…	Dentsply Intl.	1994	—

Also cleared against K933582: 1 other device →

What descends from it? (249)

See all 249

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012511	Waterlase Millennium	Biolase Technology, Inc.	2002	246
K092933	Saf (Self Adjusting File)	Redent-Nova, Ltd.	2010	0
K971319	NT Series Endodontic Files, Mac Series Endodontic Files	Tycom Dental	1997	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K012511 (Biolase Technology, Inc., 2002) has gone furthest, with 246 descendants of its own.
1 other device also cites its predicate K933582.

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 Quantec Series 2000 Endodontic Files are 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/K962031 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962031: Quantec Series 2000 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/K962031

Report an extraction error

Are you the manufacturer?

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