510(k) Report

510(k) · Cleared

Cleared

Profile Series 29 Files

K933582510(k) TraditionalCleared Oct 20, 199389-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

Tulsa Dental Products, Ltd. · EKS File, Pulp Canal, Endodontic

Cleared on Oct 20, 1993 after an 89-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 250 later devices descend from it.

Decided
Oct 20, 1993
Review
89 days
Class
Class I
Product code
EKS
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared2010: 10 descendants cleared2002: 2 descendants cleared1997: 1 descendant 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 deviceK933582 Profile Series 29 FilesTulsa Dental Products, Ltd. · 1993
  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 250 descendants. See all descendants

Descendants cleared per year

1996: 11997: 12002: 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 250 · 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)K933582Profile Series 29 FilesTulsa Dental Products, Ltd.1993—
+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
199710
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 K933582, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (250)

See all 250

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

NumberDeviceApplicantDecidedDescendants
K962031Quantec Series 2000 Endodontic FilesTycom Dental1996249
K092933Saf (Self Adjusting File)Redent-Nova, Ltd.20100

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 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

2008: 12012: 1
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

2007: 1042008: 102009: 162010: 102011: 202012: 142013: 302014: 172015: 562016: 282017: 532018: 2582019: 4682020: 4212021: 3422022: 2912023: 2642024: 3132025: 324
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—0104
20080—110
20090—016
20100—010
20110—020
20120—114
20130—030
20140—017
20150—056
20160—028
20170—053
20180—0258
20190—0468
20200—0421
20210—0342
20220—0291
20230—0264
20240—0313
20250—0324
20260—0—

More from Tulsa Dental Products, Ltd.

8 FDA decisions under this applicant name. See the company

  • K970134Thermaprep Plus OvenTulsa Dental Products, Ltd. · 1997
  • K964174Mineral Trioxide Aggregate (Mta)Tulsa Dental Products, Ltd. · 1997
  • K954790Profile Nickel Titanium Rotary InstrumentsTulsa Dental Products, Ltd. · 1996
  • K922931Thermapost Endodontic Root Canal PostTulsa Dental Products, Ltd. · 1994
  • K910224ThermaprepTulsa Dental Products, Ltd. · 1991

Recent decisions in EKS

The EKS category page

  • K062856TF Rotary Nickel Titanium FileOrmco Corp. · 2006
  • K004031NT Swift; TI\Tec; Gates Glidden Drills; Dental Power Endodontic Hand FilesDental Power, Inc. · 2001
  • K971319NT Series Endodontic Files, Mac Series Endodontic FilesTycom Dental · 1997
  • K970649HERO 642Micro-Mega · 1997
  • K962031Quantec Series 2000 Endodontic FilesTycom Dental · 1996

https://510kreport.com/device/K933582 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933582: Profile Series 29 Files.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933582

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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