510(k) Report

510(k) · Cleared

Cleared

NT Swift; TI\Tec; Gates Glidden Drills; Dental Power Endodontic Hand Files

K004031510(k) TraditionalCleared Mar 28, 200190-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

Dental Power, Inc. · EKS File, Pulp Canal, Endodontic

Cleared on Mar 28, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 28, 2001
Review
90 days
Class
Class I
Product code
EKS
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared200020052010201520202025
  1. This deviceK004031 NT Swift; TI\Tec; Gates Glidden Drills; Dental Power Endodontic Hand…Dental Power, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK082325 Apexum AblatorApexum, Ltd. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K082325Apexum AblatorApexum, Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K004031NT Swift; TI\Tec; Gates Glidden Drills; Dental Power Endodontic Hand FilesDental Power, Inc.2001—
+1K082325Apexum AblatorApexum, Ltd.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K004031, 2001–2009Source: 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 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082325Apexum AblatorApexum, Ltd.20090

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, K082325 (Apexum, Ltd., 2009) has gone furthest, with 0 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 Dental Power, Inc.

2 FDA decisions under this applicant name. See the company

  • K940680Versadowel Post SystemDental Power, Inc. · 1994

Recent decisions in EKS

The EKS category page

  • K062856TF Rotary Nickel Titanium FileOrmco Corp. · 2006
  • K971319NT Series Endodontic Files, Mac Series Endodontic FilesTycom Dental · 1997
  • K970649HERO 642Micro-Mega · 1997
  • K962031Quantec Series 2000 Endodontic FilesTycom Dental · 1996
  • K953604Shaping Hedstrom N.T.Sybron Dental Specialties, Inc. · 1995

https://510kreport.com/device/K004031 · printed Nov 5, 2026

Cite this page

510(k) Report. “K004031: NT Swift; TI\Tec; Gates Glidden Drills; Dental Power Endodontic Hand Files.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K004031

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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