510(k) Report

510(k) · Cleared

Cleared

Presterilized Endodontic Files

K943584510(k) TraditionalCleared Sep 21, 199461-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

Dentsply Intl. · EKJ Burnisher, Operative

Cleared on Sep 21, 1994 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 251 later devices descend from it.

Decided
Sep 21, 1994
Review
61 days
Class
Class I
Product code
EKJ
Recalls
None
Predicates
0

251 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1997: 2 descendants cleared2010: 10 descendants cleared2002: 2 descendants cleared2004: 2 descendants cleared2006: 3 descendants cleared2009: 5 descendants cleared2008: 11 descendants cleared2015: 12 descendants cleared2007: 4 descendants cleared2011: 7 descendants cleared2013: 10 descendants cleared2014: 11 descendants cleared2022: 24 descendants cleared2017: 7 descendants cleared2025: 29 descendants cleared2023: 14 descendants cleared2018: 13 descendants cleared2020: 14 descendants cleared2012: 4 descendants cleared2021: 10 descendants cleared2019: 7 descendants cleared2024: 24 descendants cleared2016: 10 descendants cleared2026: 15 descendants cleared1990200020102020
  1. This deviceK943584 Presterilized Endodontic FilesDentsply Intl. · 1994
  2. Descendant · cites it directly · 249 of its ownK962031 Quantec Series 2000 Endodontic FilesTycom Dental · 1996
  3. Descendant · 2 generations on · 246 of its ownK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
  4. Descendant · 3 generations on · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
  5. Descendant · 4 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
  6. Descendant · 5 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006

Showing 5 of 251 descendants. See all descendants

Descendants cleared per year

1996: 11997: 22002: 22004: 22006: 32007: 42008: 112009: 52010: 102011: 72012: 42013: 102014: 112015: 122016: 102017: 72018: 132019: 72020: 142021: 102022: 242023: 142024: 242025: 292026: 15
1996high 29 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 251 · See all
  • K962031Quantec Series 2000 Endodontic FilesTycom Dental · 1996 · cites it directly249descendants
  • K012511Waterlase MillenniumBiolase Technology, Inc. · 2002 · 2 generations on246descendants
  • K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · 3 generations on240descendants
  • K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 4 generations on226descendants
  • K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 5 generations on221descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943584Presterilized Endodontic FilesDentsply Intl.1994—
+1K962031Quantec Series 2000 Endodontic FilesTycom Dental1996—
+2K012511Waterlase MillenniumBiolase Technology, Inc.2002—
+3K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002—
+4K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004—
+5K060033Profile Multi-Platform SystemSciton, Inc2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199720
200220
200420
200630
200740
2008110
200950
2010100
201170
201240
2013100
2014110
2015120
2016100
201770
2018130
201970
2020140
2021100
2022240
2023140
2024240
2025290
2026150
FIG. 1 — Lineage of K943584, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Planning a device in EKJ? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (251)

See all 251

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

NumberDeviceApplicantDecidedDescendants
K962031Quantec Series 2000 Endodontic FilesTycom Dental1996249
K971606Sterile Flexofile Files and InstrumentsDentsply Intl.19970

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?

  • Of its descendants, K962031 (Tycom Dental, 1996) has gone furthest, with 249 descendants of its own.

How does its category compare?

All EKJ devices

EKJ Burnisher, Operative: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKJ

FDA has decided no EKJ device since 2007.

Median 510(k) review, days · EKJ

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

Recalls per year · EKJ

No recall names EKJ since 2007.

Adverse event reports per year · EKJ

2in 2015

2011: 12015: 2
2007high 2 (2015) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—02
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Dentsply Intl.

279 FDA decisions under this applicant name. See the company

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  • K070538XP Bond Dual Cure Universal Total Etch AdhesiveDentsply Intl. · 2007
  • K070019Carrara VolumiaDentsply Intl. · 2007
  • K061427Pre-Impression Conditioning SolutionDentsply Intl. · 2006

Recent decisions in EKJ

The EKJ category page

  • K961714Aseptylum, Uni-CarrierDistriflor S.A. · 1996
  • K953707Medtrol Dental KitMedtrol, Inc. · 1996
  • K945815Dental KitConstancy Ent., Inc. · 1995
  • K951607Sureflex FilesDentsply Intl. · 1995
  • K945077Instrument,Filling,Plastic,DentalWorldwide Dental, Inc. · 1994

https://510kreport.com/device/K943584 · printed Nov 4, 2026

Cite this page

510(k) Report. “K943584: Presterilized 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/K943584

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026