510(k) Report

510(k) · Cleared

Cleared

HERO 642

K970649510(k) TraditionalCleared May 16, 199785-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

Micro-Mega · EKS File, Pulp Canal, Endodontic

Cleared on May 16, 1997 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 16, 1997
Review
85 days
Class
Class I
Product code
EKS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K970649Source: FDA 510(k) database · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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.

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 Micro-Mega

2 FDA decisions under this applicant name. See the company

  • K933639Imkb Contra-AnglesMicro-Mega · 1994

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
  • K962031Quantec Series 2000 Endodontic FilesTycom Dental · 1996
  • K953604Shaping Hedstrom N.T.Sybron Dental Specialties, Inc. · 1995

https://510kreport.com/device/K970649 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970649: HERO 642.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970649

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